Cover
Cover | 12 Months Ended |
Dec. 31, 2023 shares | |
Entity Addresses [Line Items] | |
Document Type | 20-F |
Amendment Flag | false |
Document Registration Statement | false |
Document Annual Report | true |
Document Transition Report | false |
Document Shell Company Report | false |
Document Period End Date | Dec. 31, 2023 |
Document Fiscal Period Focus | FY |
Document Fiscal Year Focus | 2023 |
Current Fiscal Year End Date | --12-31 |
Entity File Number | 001-41115 |
Entity Registrant Name | Genenta Science S.p.A. |
Entity Central Index Key | 0001838716 |
Entity Incorporation, State or Country Code | L6 |
Entity Address, Address Line One | Via Olgettina No. 58 |
Entity Address, City or Town | Milan |
Entity Address, Country | IT |
Entity Address, Postal Zip Code | 20132 |
Entity Well-known Seasoned Issuer | No |
Entity Voluntary Filers | No |
Entity Current Reporting Status | Yes |
Entity Interactive Data Current | Yes |
Entity Filer Category | Non-accelerated Filer |
Entity Emerging Growth Company | true |
Elected Not To Use the Extended Transition Period | false |
Document Accounting Standard | U.S. GAAP |
Entity Shell Company | false |
Entity Common Stock, Shares Outstanding | 18,216,958 |
ICFR Auditor Attestation Flag | false |
Document Financial Statement Error Correction [Flag] | false |
Auditor Firm ID | 528 |
Auditor Name | Dannible & McKee, LLP |
Auditor Location | Syracuse, New York |
American Depositary Shares Each American Depositary Share Representing One Ordinary Share [Member] | |
Entity Addresses [Line Items] | |
Title of 12(b) Security | American depositary shares |
Trading Symbol | GNTA |
Security Exchange Name | NASDAQ |
Ordinary Shares No Par Value [Member] | |
Entity Addresses [Line Items] | |
Title of 12(b) Security | Ordinary shares |
Business Contact [Member] | |
Entity Addresses [Line Items] | |
Entity Address, Address Line One | Via Olgettina No. 58 |
Entity Address, City or Town | Milan |
Entity Address, Country | IT |
Entity Address, Postal Zip Code | 20132 |
City Area Code | +39 |
Local Phone Number | 02-2643-4681 |
Contact Personnel Name | Pierluigi Paracchi |
Contact Personnel Email Address | pierluigi.paracchi@genenta.com |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - EUR (€) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses | |||
Research and development | € 6,474,441 | € 5,338,962 | € 3,390,677 |
General and administrative | 5,258,501 | 5,705,030 | 2,296,596 |
Total operating expenses | 11,732,942 | 11,043,992 | 5,687,273 |
Loss from operations | (11,732,942) | (11,043,992) | (5,687,273) |
Other income (expense) | |||
Others income (expense) | (4,875) | 242,554 | 19,657 |
Finance income (expense) | 309,253 | 36,985 | (11,716) |
Net exchange rate gain (loss) | (216,891) | 2,286,690 | |
Awards and Subsidies | 150,000 | ||
Total other income (expense), net | 87,487 | 2,566,229 | 157,941 |
Loss before income taxes | (11,645,455) | (8,477,763) | (5,529,332) |
Income tax benefit (expense) | |||
Net loss | € (11,645,455) | € (8,477,763) | € (5,529,332) |
Net loss per share - basic | € (0.64) | € (0.47) | € (0.37) |
Net loss per share - diluted | € (0.64) | € (0.47) | € (0.37) |
Weighted average number of shares outstanding - basic | 18,216,907 | 18,216,858 | 15,083,825 |
Weighted average number of shares outstanding - diluted | 18,216,907 | 18,216,858 | 15,083,825 |
Other comprehensive income/(loss) | |||
Change in fair value of marketable debt securities Fair Value Measurement | € 214,984 | ||
Change in foreign currency translation | (15,853) | ||
Total other comprehensive income | 199,131 | ||
Comprehensive loss | € (11,446,324) | € (8,477,763) | € (5,529,332) |
Consolidated Balance Sheets
Consolidated Balance Sheets - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | |||
Cash and cash equivalents | € 3,691,420 | € 29,794,856 | € 37,240,162 |
Marketable securities | 15,084,284 | ||
Prepaid expenses and other current assets | 2,480,554 | 1,926,512 | 1,519,023 |
Total current assets | 21,256,258 | 31,721,368 | 38,759,185 |
Non-current assets | |||
Fixed assets, net | 82,977 | 111,639 | 23,090 |
Total non-current assets | 1,090,887 | 1,716,492 | 1,267,655 |
Total assets | 22,347,145 | 33,437,860 | 40,026,840 |
Current liabilities | |||
Other current liabilities | 255,062 | 297,875 | 100,719 |
Total current liabilities | 1,735,639 | 2,183,513 | 1,135,039 |
Non-current liabilities | |||
Other non-current liabilities | 14,594 | 27,218 | |
Retirement benefit obligation | 164,655 | 88,963 | 30,618 |
Total long-term liabilities | 179,249 | 116,181 | 30,618 |
Commitments and contingencies | |||
Shareholders’ equity | |||
Ordinary shares, no par value, 59,700,000 shares authorized at December 31, 2023 and 2022, respectively; 18,216,958 and 18,216,858 shares issued and outstanding at December 31, 2023 and 2022, respectively | 67,344,140 | 66,603,725 | 65,880,990 |
Accumulated deficit | (47,143,025) | (35,465,559) | (27,019,807) |
Accumulated other comprehensive income | 231,142 | ||
Total quotaholders’ and shareholders’ equity | 20,432,257 | 31,138,166 | 38,861,183 |
Total liabilities and shareholders’ equity | 22,347,145 | 33,437,860 | 40,026,840 |
Nonrelated Party [Member] | |||
Non-current assets | |||
Other non-current assets | 1,004,560 | 1,601,503 | 1,241,215 |
Current liabilities | |||
Accounts payable | 294,975 | 1,042,054 | 164,819 |
Accrued expenses | 153,136 | 202,389 | 712,313 |
Related Party [Member] | |||
Non-current assets | |||
Other non-current assets | 3,350 | 3,350 | 3,350 |
Current liabilities | |||
Accounts payable | 170,888 | 151,988 | 25,047 |
Accrued expenses | € 861,578 | € 489,207 | € 132,141 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - € / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | € 0 | € 0 |
Common Stock, shares authorized | 59,700,000 | 59,700,000 |
Common Stock, shares issued | 18,216,958 | 18,216,858 |
Common Stock, shares outstanding | 18,216,958 | 18,216,858 |
Consolidated Statement of Chang
Consolidated Statement of Changes in Quotaholders' and Shareholders' Equity - EUR (€) | Corporate Capital [Member] | Additional Paid-in Capital [Member] | Common Stock [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance at Dec. 31, 2020 | € 37,056 | € 36,604,728 | € (21,490,475) | € 15,151,309 | ||
Balance, shares at Dec. 31, 2020 | ||||||
Capital increase from exercise of options on Quota B | 715 | 715 | ||||
Share-based compensation | 497,104 | 497,104 | ||||
Quota B repurchased | (172) | (172) | ||||
Corporate capital adjustment from Srl to Spa | (37,599) | € 37,599 | ||||
Corporate capital adjustment from Srl to SpA, shares | 11,279,700 | |||||
Capital increase related to SpA | (12,401) | € 12,401 | ||||
Capital increase related to SpA, shares | 3,720,300 | |||||
Conversion adjustment from Srl to SpA | (37,089,431) | € 37,089,431 | ||||
Capital increase from IPO, net of issuance costs | € 28,741,559 | 28,741,559 | ||||
Capital increase from IPO, net of issuance costs, shares | 3,216,858 | |||||
Net loss | (5,529,332) | (5,529,332) | ||||
Cumulative Translation Adjustment | ||||||
Balance at Dec. 31, 2021 | € 65,880,990 | (27,019,807) | 38,861,183 | |||
Balance, shares at Dec. 31, 2021 | 18,216,858 | |||||
Share-based compensation | € 722,735 | 722,735 | ||||
Net loss | (8,477,763) | (8,477,763) | ||||
Cumulative Translation Adjustment | 32,011 | 32,011 | ||||
Balance at Dec. 31, 2022 | € 66,603,725 | (35,465,559) | 31,138,166 | |||
Balance, shares at Dec. 31, 2022 | 18,216,858 | |||||
Share-based compensation | € 739,884 | 739,884 | ||||
Net loss | (11,645,455) | (11,645,455) | ||||
Cumulative Translation Adjustment | ||||||
Capital increase ATM Offering | € 531 | 531 | ||||
Capital increase ATM offering, shares | 100 | |||||
Other comprehensive income | (32,011) | 231,142 | 199,131 | |||
Balance at Dec. 31, 2023 | € 67,344,140 | € (47,143,025) | € 231,142 | € 20,432,257 | ||
Balance, shares at Dec. 31, 2023 | 18,216,958 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - EUR (€) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | |||
Net loss | € (11,645,455) | € (8,477,763) | € (5,529,332) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Foreign exchange adjustment | 32,011 | ||
Depreciation expense | 42,453 | 6,140 | 4,889 |
Retirement benefit obligation | 75,692 | 58,344 | 13,231 |
Share-based compensation | 739,884 | 722,735 | 497,104 |
Changes in operating assets and liabilities | |||
Prepaid expenses and other current assets | (554,042) | (407,489) | (450,090) |
Other non-current assets | 596,943 | (427,906) | (295,597) |
Accounts payable | (747,079) | 877,235 | (380,169) |
Accounts payable - related party | 18,900 | 126,941 | 15,020 |
Accrued expenses | (49,253) | (509,924) | 346,344 |
Accrued expenses - related party | 372,371 | 357,066 | (1,227,050) |
Other current liabilities | (42,813) | 197,156 | 47,476 |
Other non-current liabilities | (12,624) | 27,218 | |
Net cash used in operating activities | (11,205,023) | (7,418,236) | (6,958,174) |
Cash flows from investing activities | |||
Purchase of marketable securities | (14,878,875) | ||
Purchases of fixed assets | (13,791) | (27,070) | (9,009) |
Net cash used in investing activities | (14,892,666) | (27,070) | (9,009) |
Cash flows from financing activities | |||
Net proceeds from IPO | 28,741,559 | ||
Proceeds from the exercise of stock options | 543 | ||
Proceeds from ATM Offering | 531 | ||
Net cash provided by financing activities | 531 | 28,742,102 | |
Effect of exchange rate changes | (6,278) | ||
Net increase (decrease) in cash and cash equivalents | (26,103,436) | (7,445,306) | 21,774,919 |
Cash and cash equivalents at beginning of period | 29,794,856 | 37,240,162 | 15,465,243 |
Cash and cash equivalents at end of period | € 3,691,420 | € 29,794,856 | € 37,240,162 |
Nature of business and history
Nature of business and history | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of business and history | 1. Nature of business and history Genenta Science S.p.A. (the “Company” or “Genenta” – formerly Genenta Science S.r.l. “società a responsabilità limitata,” similar to a Limited Liability Company in the U.S.) converted to an Italian corporation (“società per azioni”, or “S.p.A.”) in June 2021, which is similar to a C corporation in the U.S. The Company was founded in Milan, Italy by San Raffaele Hospital (“OSR”), Pierluigi Paracchi, Luigi Naldini and Bernhard Gentner, and was incorporated in July 2014. On May 20, 2021, the quotaholders (owners of the Company) resolved that the Company convert from an S.r.l. to an S.p.A. and determined that the outstanding quota be converted to 15 On December 17, 2021, the Company completed an initial public offering (“IPO”) of its shares. The shares began trading on the Nasdaq Stock Capital Market on December 15, 2021. Through the IPO, 3,120,114 720,114 2,400,000 96,744 18,216,858 29 3.9 On May 12, 2023, the Company filed with the Securities and Exchange Commission (the “SEC”) a shelf registration statement that was subsequently declared effective on May 24, 2023. It permits the Company to sell from time-to-time ordinary shares, including ordinary shares represented by ADSs, or rights to subscribe for ordinary shares or ordinary shares represented by ADSs in one or more offerings in amounts, at prices and on the terms that the Company will determine at the time of offering for aggregate gross sale proceeds of up to $ 100.0 In July 2023, the Company issued 100 ADSs for gross proceeds of approximately $ 639 18,216,958 the Company mutually agreed with Cantor to terminate the Sales Agreement. Genenta is an early-stage company developing first-in-class cell and gene therapies to address unmet medical needs in cancerous solid tumors. The Company is initially developing its clinical leading product, Temferon™, to treat glioblastoma multiforme (“GBM”), a solid tumor affecting the brain. The Company intends to continue its clinical trials in Italy, and eventually start a clinical trial in Europe and the U.S. to study Temferon™ in other cancers. In June 2023, the Company’s Board of Directors selected Renal Cell Cancer (“RCC”) as the second solid tumor indication for Temferon. The Company is currently developing a clinical plan for RCC. The Company is subject to risks and uncertainties common to early-stage clinical companies in the life-science and biotechnology industries, including but not limited to, risks associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new competing products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. The clinical product candidates currently under development will require significant additional research and development efforts, including regulatory approval and clinical testing prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales and profit from operations. Liquidity and risks The Company has incurred losses since its inception, including a net loss of € 11.6 8.5 5.5 47.1 18.8 The Company has evaluated whether there are conditions and events considered in the aggregate that raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s business model, typical of biotechnology companies developing new therapeutic products that have not reached a balanced income and financial position, features negative cash flows. This is because, at this stage, costs must be borne in relation to services and personnel, directly connected to research and development activities, and return for these activities is not certain and, in any case, it is expected in future years. Based on the accounting policies adopted, requiring full recognition of research and development costs in the statement of operations and comprehensive loss in the year they are incurred, the Company has reported a loss since its inception, and expects to continue to incur significant costs for research and development in the foreseeable future. There is no certainty that the Company will become profitable in the future. The Company will require additional capital to meet its long-term operating requirements. It expects to raise additional capital through, among other things, the sale of equity or debt securities, which may include sales of ADSs pursuant to the ATM Offering. If adequate funds are not available in the future, the Company may be forced to delay, reorganize, or cancel research and development programs, or to enter into financing, licensing or collaboration agreements with unfavorable conditions or waive rights to certain products which otherwise it would not have waived, resulting in negative effects on the activity and on the economic, patrimonial and /or financial situation of the Company. The Company’s ability to raise additional capital may be adversely impacted by the potential worsening of global economic and political conditions and volatility in the credit and financial markets in the U.S. and worldwide. This could be exacerbated by, among other factors, the lingering effects of the COVID-19 pandemic and its ongoing variants, the war between Russia and Ukraine, and/or the Israeli and Hamas war. The Company’s failure to raise capital as and when needed or on acceptable terms could have a negative impact on the Company’s financial condition and its ability to pursue its business strategy, and the Company may have to delay, reduce the scope of, suspend or eliminate one or more of its research-stage programs, clinical trials, or future commercialization efforts. Quantitative and qualitative disclosure about market risk The Company is exposed to market risks in the ordinary course of its business. Market risk represents the risk of loss that may impact the Company’s financial position due to adverse changes in financial market prices and rates. The Company’s current investment policy is conservative due to the need to support operations. The Company invests available cash in bank time deposits with reputable banks that have a credit rating of at least “A” and Italian and U S government treasury notes and bonds with short term maturity. A minority of the Company’s cash and cash equivalents and marketable securities are held in deposits that bear a small amount of interest. The Company’s market risk exposure is primarily a result of foreign currency exchange rates, which is discussed in detail in the following paragraph. The Company is an early-stage cell and gene therapy company commercializing technology licensed from OSR. The Company intends to continue to conduct its operations so that neither it nor its subsidiary is required to register as an investment company under the Investment Company Act of 1940, as amended, and the rules and regulations promulgated thereunder (the “40 Act”). To ensure that the Company does not become subject to regulation under the ‘40 Act, the Company may be limited in the type of assets that it may own or acquire. If the Company were to become inadvertently subject to the ‘40 Act, any violation of the ‘40 Act could subject the Company to material adverse consequences. Foreign currency exchange risk The Company’s results of operations and cash flow may be subject to fluctuations due to changes in foreign currency exchange rates. The Company’s liquid assets and expenses are denominated in EUR and USD. At December 31, 2023, the Company maintained € 3.7 15.1 Currently, the Company has recorded an unrealized net loss from exchange rate of approximately € 0.2 |
Summary of significant accounti
Summary of significant accounting policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies | 2. Summary of significant accounting policies Basis of presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) for consolidated financial information and with the instructions to Form 20-F and Article 10 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to the authoritative US GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”), unless otherwise stated. A summary of the significant accounting policies applied in the preparation of these consolidated financial statements is presented below, only for the categories and headings now applicable and that might be applicable in the future based on the Company’s business. These policies have been consistently applied, unless otherwise stated. Principles of consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. Use of estimates The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts reported in the financial statements and the disclosures made in the accompanying notes. Estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses and related milestone payments, share-based compensation expense, valuation of Research & Development (“R&D”) tax credits, the valuation of equity and the recoverability of the Company’s net deferred tax assets and related valuation allowance. Estimates are periodically reviewed considering changes in circumstances, facts, and experience. Actual results may differ from these estimates under different assumptions or conditions. Changes in estimates are recorded in the period in which they become known. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed below. Cash and cash equivalents The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents, which amounts may at times exceed federally insured limits. The Company has not experienced any losses on such accounts and does not believe it is exposed to any significant credit risk. In the consolidated cash flow statements, cash and cash equivalents include: cash on hand, deposits held with banks, and other short-term highly liquid investments. In the consolidated balance sheets, bank overdrafts, if any, are shown in current liabilities. Cash and cash equivalents are detailed as follows: Schedule of cash and cash equivalents 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) (Euro) Cash in bank € 3,687,402 € 29,790,838 € 37,236,089 Cash in hand & prepaid cards 4,018 4,018 4,073 Total € 3,691,420 € 29,794,856 € 37,240,162 Marketable securities The Company’s marketable securities are maintained by investment managers and consist of highly rated foreign government debt securities. Debt securities are carried at fair value with the unrealized gains and losses included in other comprehensive income (loss) as a component of shareholders’ equity until realized. Any premium arising at purchase is amortized to the earliest call date and any discount arising at purchase is accreted to maturity. Amortization and accretion of premiums and discounts are recorded in interest income, net. Realized gains and losses on debt securities are determined using the specific identification method and are included in other income (expense), net. The Company classifies marketable securities with a remaining maturity when purchased of greater than three months as available-for-sale. Marketable securities with a remaining maturity date greater than one year are classified as non-current assets. Effective January 1, 2023, the Company adopted ASU 2016-13 , Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements The Company assesses its available-for-sale debt securities under the available-for-sale debt security impairment model in ASC 326 as of each reporting date in order to determine if a portion of any decline in fair value below carrying value recognized on its available-for-sale debt securities is the result of a credit loss. The Company records credit losses in the consolidated statements of operations and comprehensive loss as credit loss expense within other income (expense), net, which is limited to the difference between the fair value and the amortized cost of the security. To date, the Company has not recorded any credit losses on its available-for-sale debt securities. Accrued interest receivable related to the Company’s available-for-sale debt securities is presented within receivables and other current assets on the Company’s consolidated balance sheets. The Company has elected the practical expedient available to exclude accrued interest receivable from both the fair value and the amortized cost basis of available-for-sale debt securities for the purposes of identifying and measuring any impairment. The Company writes off accrued interest receivable once it has determined that the asset is not realizable. Any write offs of accrued interest receivable are recorded by reversing interest income, recognizing credit loss expense, or a combination of both. To date, the Company has not written off any accrued interest receivables associated with its marketable securities. The unrealized gain recognized during the reporting period on marketable securities still held at the report date was approximately € 268,000 53,000 Net loss and comprehensive income (loss) Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. ASC 220 Comprehensive Income requires that an entity records all components of comprehensive (loss) income, net of their related tax effects, in its financial statements in the period in which they are recognized. For the years ended December 31, 2023, net loss was € 11.6 199,131 11.4 Net loss per share Net loss per share (“EPS”) is computed in accordance with US GAAP. Basic EPS is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted EPS reflects potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period increased by the number of additional common shares that would have been outstanding if all potential common shares had been issued and were dilutive. The EPS calculation was applied at the Company conversion to S.p.A. in June 2021, after the increase in capital to € 50,000 59.7 100 18,216,958 2.7 At December 31, 2023, the Company had 382,785 23,502 382,785 23,502 Foreign currency translation The reporting and functional currency of the Company is Euros. All amounts are presented in Euros unless otherwise stated. All amounts disclosed in the consolidated financial statements and notes have been rounded to the nearest Euro unless otherwise stated. Foreign currency transactions, if any, are translated into Euros using the exchange rates prevailing at the date(s) of the transaction(s) or valuation where items are re-measured. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statements of operations. For financial reporting purposes, the assets and liabilities of the U.S. Subsidiary are translated into EUR using exchange rates in effect at the balance sheet date. The net income/(loss) of the U.S. Subsidiary is translated into EUR using average exchange rates in effect during the reporting period. The resulting currency translation impact is recorded in Shareholders’ equity as a cumulative translation adjustment. For 2023, the currency translation impact was approximately € 15,800 0.2 The net exchange gain was approximately € 2.3 1.6 12.0 0.4 0.3 Emerging growth company status The Company is an “emerging growth company,” as defined in the U.S. Jumpstart Our Business Startups Act, or U.S. JOBS Act, and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. The Company may take advantage of these exemptions until the Company is no longer an “emerging growth company.” Section 107 of the U.S. JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period afforded by the U.S. JOBS Act for the implementation of new or revised accounting standards. The Company has elected to use the extended transition period for complying with new or revised accounting standards and, because of this election, its consolidated financial statements may not be comparable to companies that comply with public company effective dates. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of its initial public offering (“IPO”) or such earlier time that it is no longer an “emerging growth company.” Fair value measurements Certain assets and liabilities of the Company are carried at fair value under US GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1 — Quoted prices in active markets for identical assets or liabilities. ● Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying values of the Company’s R&D tax credits, VAT credits, accounts payable, accrued expenses and other current liabilities were evaluated and determined to approximate their fair values due to the short-term nature of these assets and liabilities. Schedule of fair values due to short-term nature of assets and liabilities Total Level 1 Level 2 Level 3 December 31, 2023 Total Level 1 Level 2 Level 3 Cash and cash equivalents € 3,691,420 3,691,420 € - € - Marketable Securities 15,084,284 15,084,284 - - Total financial assets € 18,775,704 € 18,775,704 € - € - Total Level 1 Level 2 Level 3 December 31, 2022 Total Level 1 Level 2 Level 3 Cash and cash equivalents € 29,794,856 29,794,856 € - € - Total financial assets € 29,794,856 € 29,794,856 € - € - Total Level 1 Level 2 Level 3 December 31, 2021 Total Level 1 Level 2 Level 3 Cash and cash equivalents € 37,240,162 37,240,162 € - € - Total financial assets € 37,240,162 € 37,240,162 € - € - Segment information Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company and its chief operating decision-maker view the Company’s operations and manages its business in one operating segment, which is the research and development in the pharmaceutical sector with a focus on developing novel therapeutics to treat cancer. Tax credit on investments in research and development In line with the legislation in force at December 31, 2023, and 2022, companies in Italy that invest in eligible research and development activities, regardless of the legal form and economic sector in which they operate, can benefit from a tax credit which can be used in order to reduce most taxes payable, including income tax or regional tax on productive activities, as well as social security contributions and payroll withholding taxes. For eligible research and development activities, the tax credit was equal to 20% in fiscal year 2022 (“FY 2022”) of the eligible costs incurred, with a maximum annual amount of € 4.0 5.0 The eligible activities consist of fundamental research, industrial research, and experimental development as defined respectively of the letters m), q) and j) of point 15, par. 1.3 of the Communication no. 198/2014 of the European Commission. To determine the cost basis of the benefit, the following expenses are eligible: ● Personnel costs; ● Depreciation charges, costs of the financial or simple lease and other expenses related to movable tangible assets and software used in research and development projects; ● Expenses for extra-euro research contracts concerning the direct execution of eligible research and development activities by the provider; ● Depreciation charges; ● Expenses for consulting services and equivalent services related to eligible research and development activities; and, ● Expenses for materials, supplies, and other similar products used in research and development projects. The Company, by analogy, accounts for this receivable in accordance with International Accounting Standards (IAS) 20, Accounting for Government Grants and Disclosure of Government Assistance While these tax credits can be carried forward indefinitely, the Company recognized an amount which reflects management’s best estimate of the amount that is reasonably assured to be realized or utilized in the foreseeable future based on historical benefits realized, adjusted for expected changes, as applicable. The tax credits are recorded as an offset to research and development expenses in the Company’s Consolidated Statements of Operations and Comprehensive Loss . Share-based compensation To reward the efforts of employees, directors, and certain consultants and to promote the growth of the Company, the Company’s Board of Directors has approved, prior to the Company’s conversion to an S.p.A., various share-based awards. All options have been awarded with an exercise price of €1 per quota and, when exercised, all options have been converted to Quota B. The options granted had the vesting condition that the individual must remain in his/her role at least one year or as otherwise specified for each person. In May 2021, the Company’s quotaholders adopted the Company’s “Equity Incentive Plan 2021–2025” (“the Plan”); however, through December 31, 2021, no options or awards were granted and there were no outstanding options or awards. (See Note 12. Share-based compensation.) In April 2022, the Company’s board of directors, as administrator of the Plan, awarded nonqualified stock options (“NSOs”) on 147,783 In July 2022, the Company’s board of directors, as administrator of the Plan, awarded NSOs on 392,740 In March 2023, the board of directors, as administrator of the Plan, awarded NSOs on 46,400 In June 2023, the Company’s shareholders modified the Plan to extend the final deadline for the issuance of the ordinary shares until December 31, 2035, in order to allow that all stock options granted during the term of the Plan could provide for an exercise period of 10 years starting from the date of grant. (See Note 12. Share-based compensation.) Currently, the Company has authorized options on 1,821,695 10 18,216,958 2,700,000 2,700,000 27,000,000 586,923 1,234,772 The Company measures its stock option awards granted to employees, officers, directors, and consultants under the Plan based on their fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is normally 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. The Company classifies stock-based compensation expense in its Consolidated Statement of Operations and Comprehensive Loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. The Company chose the Black-Scholes-Merton model because it is considered easier to apply and also it is a defined equation and incorporates only one set of inputs. As a result, it is the model most commonly in use. Representative warrants The Company agreed to issue warrants to the underwriters of the IPO (“Warrants”) to purchase 23,502 14.375 The Warrants will provide for adjustment in the number and price of the Warrants and the ADSs underlying such Warrants in the event of recapitalization, merger, stock split or other structural transaction, or a future financing undertaken by the Company. The Warrants were evaluated under applicable guidance and accordingly classified as equity in the consolidated financial statements. Non-current assets right of use (ROU) Upon commencement of a contract containing a lease, the Company classifies leases other than short-term leases as either an operating lease or a finance lease according to the criteria prescribed by ASC 842. The Company recognizes both lease liabilities and right-of-use assets on the balance sheet for all leases, except for short-term leases (those with a lease term of 12 months or less). Lease liabilities are initially measured at the present value of the future lease payments over the lease term, discounted at the rate implicit in the lease or, if that rate is not readily determinable, the Company’s incremental borrowing rate. The right-of-use assets represent the lessee’s right to use the underlying asset for the lease term and are initially measured at the same amount as the corresponding lease liability. For finance leases, the Company recognizes interest expense on the lease liability and amortization expense on the right-of-use asset. For operating leases, lease expense is recognized on a straight-line basis over the lease term. Fixed Assets Property and equipment are stated at cost, including any accessory and direct costs that are necessary to make the assets fit for use, and adjusted by the corresponding accumulated depreciation. Depreciation is systematically recorded in the consolidated financial statements taking into consideration the use, purpose, and financial-technical duration of the assets, based on their estimated useful economic lives. Leasehold improvements depreciation is recorded based on the shorter of the life of the leasehold improvement or the remaining term of the lease. Ordinary maintenance costs are expensed to the Consolidated Statements of Operations and Comprehensive Loss in the year in which they are incurred. Extraordinary maintenance costs, the purpose of which is to extend the useful economic life of the asset, to technologically upgrade it and/or to increase its productivity or safety for the purpose of economic productivity of the Company, are attributed to the asset to which they refer and depreciated on the basis of its estimated useful economic life. Amortization of leasehold improvements is computed using the straight-line method based upon the terms of the applicable lease or estimated useful life of the improvements, whichever is less. Impairment of long-lived assets In accordance with ASC Topic 360-10-20, “Property, Plant and Equipment,” the Company performs an impairment test whenever events or circumstances indicate that the carrying value of long- lived assets with finite lives may be impaired. Impairment is measured by comparing the carrying value of the long-lived assets to the estimated undiscounted pre-tax cash flows expected to result from the use of such assets and their ultimate disposition. In circumstances where impairment is determined to exist, the Company will write down the asset to its fair value based on the present value of estimated cash flows. To date, no impairments have been identified for the periods ended December 31, 2023, and 2022. Deferred offering costs Deferred public offering costs, which primarily consist of direct, incremental legal and accounting fees relating to fundraising activities (e.g., an IPO), were capitalized within prepaid expenses and other current assets prior to the IPO and netted or offset with the IPO proceeds upon closing of the IPO. For the year ended December 31, 2023, the Company incurred approximately € 0.3 For the year ended December 31, 2022, the Company did not incur offering costs. For the year ended December 31, 2021, the Company incurred approximately € 3.9 156,000 Recently issued accounting pronouncements In April 2012, the U.S. Jump-Start Our Business Startups Act (the “U.S. JOBS Act”) was signed into law. The U.S. JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company may elect to adopt new or revised accounting standards when they become effective for non-public companies, which typically is later than when public companies must adopt the standards. The Company has elected to take advantage of the extended transition period afforded by the U.S. JOBS Act and, as a result, unless the Company elects early adoption of any standards, will adopt the new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-public companies. In December 2019, the FASB issued ASU 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes. The new standard intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intra-period tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. For non-public entities, the standard is effective for annual periods beginning after December 15, 2021, with early adoption permitted. Adoption of the standard requires certain changes to primarily be made prospectively, with some changes to be made retrospectively. The Company is currently evaluating the impact that the adoption of ASU 2019-12 will have on its consolidated financial statements. In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance. The aim of ASU 2021-10 is to increase the transparency of government assistance including the disclosure of (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on an entity’s financial statements. Diversity currently exists in the recognition, measurement, presentation, and disclosure of government assistance received by business entities because of the lack of specific authoritative guidance in GAAP. The ASU will be effective for annual reporting periods after December 15, 2021, and early adoption is permitted. Upon implementation, the Company may use either a prospective or retrospective method of adoption when adopting the ASU. The Company is evaluating the impact of adopting the new ASU. In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging —Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This ASU amends the guidance on convertible instruments and the derivatives scope exception for contracts in an entity’s own equity and improves and amends the related EPS guidance for both Subtopics. The ASU will be effective for annual reporting periods after December 15, 2023, and interim periods within those annual periods and early adoption is permitted in fiscal periods ending after December 15, 2020. Upon implementation, the Company may use either a modified retrospective or full retrospective method of adoption. The Company is evaluating the impact of adopting the new ASU. |
Research and development
Research and development | 12 Months Ended |
Dec. 31, 2023 | |
Research and Development [Abstract] | |
Research and development | 3. Research and development Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries, share- based compensation and benefits, facilities costs, third-party license fees, and external costs of outside vendors and consultants engaged to conduct clinical development activities and clinical trials, (e.g., contract research organizations, or CROs), as well as costs to develop a manufacturing processes, perform analytical testing and manufacture clinical trial materials, (e.g., contract manufacturing organizations, or CMOs). Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered, or the services rendered. In addition, funding from research grants, if any, is recognized as an offset to research and development expense based on costs incurred on the research program. The Company annually sustains a significant amount of research costs to meet its business objectives. The Company has various research and development contracts, and the related costs are recorded as research and development expenses as incurred. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of outstanding obligations at period end to those third parties. Any accrual estimates are based on several factors, including the Company’s knowledge of the progress towards completion of the research and development activities, invoicing to date under the contracts, communication from the research institution or other companies of any actual costs incurred during the period that have not yet been invoiced, and the costs included in the contracts. Significant judgments and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ from the estimates made by the Company. The historical accrual estimates made by the Company have not been materially different from the actual costs. For further details, please refer to the Related Parties disclosures in Note 13 below. |
General and administrative
General and administrative | 12 Months Ended |
Dec. 31, 2023 | |
General And Administrative | |
General and administrative | 4. General and administrative General and administrative costs consist primarily of salaries, share-based compensation, benefits and other related costs for personnel and consultants in the Company’s executive and finance functions, professional fees for legal, finance, accounting, auditing, tax and consulting services, travel expenses and facility-related expenses, which include rent and maintenance of facilities and other operating costs not otherwise included in research and development expense. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income taxes | 5. Income taxes The Company is subject to taxation in Italy, and with the addition of the Company’s wholly owned subsidiary in the U.S., the Company is subject to taxation in the U.S. Taxation in Italy includes the standard corporate income tax and a regional business tax. Taxation in the U.S. includes federal corporate income tax (“IRS”), as well as state and local taxes. Taxes are recorded on an accrual basis. They therefore represent the allowances for taxes paid or to be paid for the year, calculated according to the current enacted rates and applicable laws. In the future, the Company may be taxed in various other countries where it may have permanent establishments, as applicable. For the period ending December 31, 2023, 2022 and 2021, due to the tax loss position reported, no income taxes were due in Italy or in the U.S., although the U.S. subsidiary had taxable income in 2022. In addition, the subsidiary in the U.S. had an immaterial amount of other state taxes. The Company uses the asset and liability method of accounting for deferred income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities, measured at tax rates expected to be enacted at the time of their reversals. These temporary differences primarily relate to net operating losses carried forward available to offset future taxable income. At each reporting date, the Company considers existing evidence, both positive and negative, that could impact its view with regards to future realization of deferred tax assets. In consideration of the start-up status of the Company, a valuation allowance has been established to offset the deferred tax assets, as the related realization is currently uncertain. In the future, should the Company conclude that it is more likely than not that the deferred tax assets are partially or fully realizable, the valuation allowance will be reduced to the extent of such expected realization, and the corresponding amount will be recognized as income tax benefit in the Company’s Consolidated Statements of Operations and Comprehensive Loss. The Company recognizes tax liabilities from an uncertain tax position if it is more likely than not that the tax position will not be sustained upon examination by the taxing authorities, based on the technical merits of the tax position. There are no uncertain tax positions that have been recognized in the accompanying consolidated financial statements. For the Italian Company, the prior five years of tax returns (2019-2023) are potentially subject to audit, for the Subsidiary in the U.S. the open years for tax examination are 2021, 2022 and 2023. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. A reconciliation of the Company’s effective tax rate is summarized as follows: Schedule of effective income tax rate reconciliation 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) Income taxes at Italy statutory rate € (2,794,909 ) € (2,034,663 ) € (1,296,797 ) Permanent differences 309,512 (160,133 ) (1,189,844 ) Other (171,032 ) 715 (29,928 ) Federal Income tax for Genenta INC (89,910 ) (31,993 ) (26,462 ) Change in valuation allowance 2,746,339 2,226,074 2,543,031 Total provision expense for income taxes € - € - € - Significant components of the Company’s net deferred tax assets are summarized as follows: Schedule of deferred tax assets 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) Deferred tax assets Net operating loss carryforwards € 11,772,870 € 9,197,563 € 7,125,174 Other temporary differences 150,347 52,996 6,000 Allowance for corporate equity 495,692 422,011 315,322 Total deferred tax assets 12,418,909 9,672,570 7,446,496 Valuation allowance (12,418,909 ) (9,672,570 ) (7,446,496 ) Net deferred tax assets € - € - € - At December 31, 2023, 2022 and 2021, the Company believes there are no significant differences with regards to its deferred tax assets and its relevant components, compared to the computations of the preceding periods. In 2011, the Italian tax authorities issued a set of rules that modified the previous treatment of tax loss carryforwards. According to the DL 98/2011, at the end of 2011, all existing tax loss carryforwards will never expire but they can off-set only 80 The following table shows the amount of deferred tax assets that can be carried forward indefinitely and used without limitation or with the limit of 80% of taxable income generated in Italy, as provided by Legislative Decree 98/2011: Schedule of tax loss carryforwards expire 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) No expiration date € 5,487,085 € 5,487,085 € 5,487,085 No expiration date - DL 98/2011 43,191,915 33,054,966 24,241,891 Total € 48,679,000 € 38,542,051 € 29,728,976 The Company has analyzed its tax position by determining the amount of tax losses that can be carried forward indefinitely and has decided to accrue an allowance for related deferred tax assets as the Company is in a situation of pre-revenues that is destined to remain in the long run and there is no certainty of the future recoverability of such tax losses through tax relevant incomes. Future taxable profits for the Company depend on the manufacture of marketable drugs following the successful completion of the clinical trial. Since the clinical trial is still in Phase I/2A, the time frame and uncertainties regarding the outcome of the completion justify the full allowance of deferred tax assets. |
Prepaid expenses and other curr
Prepaid expenses and other current assets | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid expenses and other current assets | 6. Prepaid expenses and other current assets Prepaid expenses and other current assets consist of the following: Schedule of prepaid expenses and other current assets 2023 2022 2021 At December 31, 2023 2022 2021 (Euro) Value Added Tax (VAT) € 1,170,634 € 912,423 € 820,780 Research and development tax credit 833,000 650,000 600,000 Advances payments to suppliers 34,108 41,149 58,009 Other current assets 64,664 219,400 21,987 Other prepaids 378,148 103,540 18,247 Total € 2,480,554 € 1,926,512 € 1,519,023 Value Added Tax (VAT) receivables are linked to purchases. Italian VAT ( Imposta sul Valore Aggiunto 22 Tax credits on research and development represent a special tax relief offered to Italian companies operating in the research and development sector and can be used to offset most taxes payable. The Company has a total research and development tax credit available to be used of approximately € 4.1 4.4 During the 12 months period ended December 31, 2023, the Company utilized approximately € 732,000 600,000 430,000 698,000 Advance payments to suppliers at December 31, 2023 and 2022 mainly relate to R&D operating services. Other current assets at December 31, 2023 mainly relate to interests maturing on investment in marketable securities, while Other current assets at December 31, 2022 mainly relate to the allowance for corporate equity (“ACE”) of approximately € 180,000 38,000 At December 31, 2023, Other prepaid expenses mainly relate to the directors and officers (“D&O”) insurance policy paid in December 2023 of approximately € 0.2 |
Fixed assets, net
Fixed assets, net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Fixed assets, net | 7. Fixed assets, net Fixed assets consist of the following: Schedule of fixed assets,net 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) Software (ERP Implementation) € 87,800 € 87,800 € - Computer 35,971 31,307 24,869 Furniture and fixtures 13,005 4,676 5,010 Total fixed assets 136,776 123,783 29,879 Less: accumulated depreciation (53,799 ) (12,144 ) (6,789 ) Fixed assets, net € 82,977 € 111,639 € 23,090 For the period ended December 31, 2023 and 2022 software was approximately € 53,144 87,800 Equipment consists of computers and furniture and fixtures of our office space in Milan, Italy. There were no significant disposals, nor impairments during the periods. Depreciation has been calculated by taking into consideration the use, purpose, and financial-technical duration of the assets, based on their estimated economic lives. No significant purchases occurred during the period ended December 31, 2023. |
Non-current assets right of use
Non-current assets right of use (ROU) | 12 Months Ended |
Dec. 31, 2023 | |
Non-current Assets Right Of Use | |
Non-current assets right of use (ROU) | 8. Non-current assets right of use (ROU) In February 2022, the Company entered into a four-year (i.e., 48 month) lease of an automobile, with an ending date of January 2026. The “base” annual lease payment is € 13,967 1,164 lease payment will remain fixed for the four (4) years For the initial measurement, the calculation of the net present value of the right of use asset and liability was made by using the discounted rate of 6.25 49,320 27,200 12,600 14,600 |
Other non-current assets
Other non-current assets | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other non-current assets | 9. Other non-current assets Other non-current assets consist of the long-term portion of the VAT receivable and R&D tax credit, as follows: Schedule of other non-current assets 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) Value Added Tax (VAT) € 630,342 € 912,424 € 641,215 Research and development tax credit 167,000 650,000 600,000 Other non-current assets 207,218 39,079 Total other non-current assets € 1,004,560 € 1,601,503 € 1,241,215 The VAT tax credit matured in 2023 and is expected to become eligible for reimbursement after twelve months from December 31, 2023. The R&D tax credit long term decreased in 2023, mainly because of the decrease in the percentage of eligible R&D expense that by law was reduced from 20 10 Other non-current assets mainly include the allowance for corporate equity (“ACE”) of approximately € 0.2 In addition, other non-current assets - related party includes a security deposit of € 3,350 |
Retirement benefit obligation
Retirement benefit obligation | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Retirement benefit obligation | 10. Retirement benefit obligation Employees in Italy are entitled to Trattamento di Fine Rapporto (“TFR”), commonly referred to as an employee leaving indemnity, which represents deferred compensation for employees in the private sector. Under Italian law, an entity is obligated to accrue for TFR on an individual employee basis payable to each individual upon termination of employment (including both voluntary and involuntary dismissal). The annual accrual is approximately 7 Compensation – Retirement Benefits 164,655 88,963 |
Quotaholders_ and shareholders_
Quotaholders’ and shareholders’ equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Quotaholders’ and shareholders’ equity | 11. Quotaholders’ and shareholders’ equity The Company was an S.r.l., which is an Italian limited liability company like a limited liability company in the U.S., prior to May 2021. The Articles of Incorporation, Shareholders’ Agreement and the By-laws of the Company provided for different quotas, which represented the Company’s corporate capital, rather than shares of stock as ownership. Corporate capital As an S.r.l., the Company’s ownership was called “corporate capital” and “quotas” rather than shares, stock, or units. The Company’s capital was divided between five (5)categories of quotas as summarized below at January 1, 2021: Schedule of equity method investment and ownership percentage At January 1, Ownership Quota 2021 % A € 10,458 28 % B 6,886 19 % C 8,645 23 % D 4,034 11 % E 7,033 19 % Total € 37,056 100 % The Company had five (5) categories of quotas: ● Quota A was reserved for certain founders. One of the founders had the right to appoint three (3) board members out of five (5), appoint the Chair from these three (3) persons and appoint one (1) member of the board of statutory auditors. One other founder had the right to appoint two (2) board members out of five (5), appoint two (2) statutory auditors and appoint the Chair of the statutory auditors from the two (2) appointees. Quota A had voting rights. ● Quota B had no voting rights 1.00 ● Quota C had the right to appoint one (1) member of the board of statutory auditors; specifically, the one (1) that a founder had the right to appoint. ● Quota D and Quota E had no rights. ● Quotas A, C, D & E. During a divestiture proceeding (meaning Quotas representing 100 50 50 During the year ended December 31, 2021, the following events occurred which together had a significant impact on the Company’s equity: On April 1, 2021, the Board of Directors resolved to grant to employees and non-employees stock options and accelerate the vesting of other stock options on € 715 172 543 1 37,771 37,056 715 On May 20, 2021, at a Quotaholders’ meeting, the Quotaholders resolved to convert the Company from an S.r.l. to an S.p.A., which conversion became effective on June 18, 2021. As consequence of the conversion, the Corporate Capital was converted to ordinary shares with no par value, and it was increased to € 50,000 As a result of the Company conversion, the corporate capital was reclassified as ordinary shares, no par value, combining the minimum capital amount of € 50,000 37,139,431 50,000 15 300 On December 15, 2021, the Company completed the IPO of its shares and was listed on the Nasdaq Stock Capital Market. Through the IPO, 3,120,114 720,114 2.4 96,744 18,216,858 29 3.9 |
Share-based compensation
Share-based compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-based compensation | 12. Share-based compensation The Company granted options on its corporate capital to certain directors, officers, employees, and consultants, as an incentive and as additional compensation prior to the Company’s conversion to an S.p.A. All options converted into Quota B when vested and exercised. In April 2021, € 172 169 546 715 In May 2021, in context of our Corporate Conversion from a limited liability company (società a responsabilità limitata, or “S.r.l.”) to a joint stock company (società per azioni, or an “S.p.A.”), the shareholders approved a capital increase to allow for issuance of up to 2.7 10 In April 2022, the Company’s board of directors, as administrator of the Plan, awarded a nonqualified stock option (“NSO”) on 147,783 6.38 In July 2022, the Company’s board of directors, as administrator of the Plan, awarded NSOs on 392,740 The director NSOs vested monthly over a one-year period with a 10-year term. The officer and employee NSOs vested monthly over a four (4) year period with a 10-year term; however, the vesting of the officer NSOs were adjusted based on hire date per their employment contracts 4.76 At December 31, 2022, there were 540,523 1,281,162 In March 2023, the Board, as administrator of the Plan, awarded NSOs on 46,400 5.62 At December 31, 2023, there were 586,923 1,234,772 The Company calculates the fair value of stock options awards granted to employees and nonemployees using the Black-Scholes option-pricing method. If the company determinates that other methods are more reasonable, or other methods for calculating these assumptions are prescribed by regulators, the fair value calculated for the Company’s stock options could change significantly. Higher volatility and longer expected lives would result in an increase to share-based compensation expense to non-employees determined at the date of grant. Share-based compensation expense to non-employees affects the Company’s selling, general and administrative expenses and research and development expenses. The Company calculated the share compensation expense for the options granted by utilizing the Black Scholes method with the following inputs for each of the stock grants in March 2023, July 2022 and April of 2022: ● The option’s exercise price. ● The option’s expected term. ● The underlying share’s current price. ● The underlying share’s expected price volatility during the option’s expected (or in certain cases, contractual) term, or in cases where calculated value is used, the historical volatility of an appropriate industry sector index. ● The underlying share’s expected dividends during the option’s expected (or in certain cases, contractual) term except cases, such as when dividend protection is provided; and ● The risk-free interest rate during the option’s expected (or in certain cases, contractual) term. Schedule of Outstanding Stock Options Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding as of January 1, 2021 546 € 1.00 1 € 584,132 Granted 169 1.00 - 183,831 Vested and exercised 715 1.00 - 777,920 Cancelled or forfeited - - - - Outstanding as of December 31, 2021 - € - - € - Exercisable as of December 31, 2021 - € - - € - Outstanding, expected to vest as of December 31, 2021 - € - - € - Outstanding as of January 1, 2022 - - - - Granted 540,523 € 4.99 7.3 € 272,480 Vested and exercised - - - - Cancelled or forfeited - - - - Outstanding as of December 31, 2022 540,523 € 4.99 7.3 € 272,480 Exercisable as of December 31, 2022 237,129 € 5.66 4.42 € 61,988 Outstanding, expected to vest as of December 31, 2022 303,394 € 4.67 9.55 € 210,492 Outstanding as of January 1, 2023 540,523 € 4.99 7.3 € 272,480 Granted 46,400 5.30 9.17 - Vested and exercised - - - - Cancelled or forfeited - - - - Outstanding as of December 31, 2023 586,923 € 4.84 6.53 € 67,596 Exercisable as of December 31, 2023 382,785 € 5.11 5.44 € 33,796 Outstanding, expected to vest as of December 31, 2023 204,138 € 4.34 8.58 € 33,800 On March 2023, the Company granted non-qualified stock options to certain directors were partially vested and priced based on the “2021-2025 -Plan.” Total recognized expense was approximately € 199,890 On July 2022, the Company granted non-qualified stock options to certain directors and employees that were partially vested and priced based on the “2021-2025 Plan.” Total recognized expense was approximately € 482,692 On April 2022, the Company granted non-qualified stock options to Dr. Squinto, Chairman of the Company at that time, that were fully vested and priced based on a Sub-Plan called “2021-2025 Chairman Sub-Plan” attached to the Plan. Total recognized expense was € 240,043 At December 31, 2021, there were no The Company’s share-based compensation expense for the years ended December 31, 2023, 2022 and 2021 is represented by the following table: Schedule of share based compensation expenses 2023 2022 2021 Year ended December 31 2023 2022 2021 (in Euros) Research & development expense € 73,392 € 35,164 € 82,669 Research & development expense - related party - - 179,480 General & administrative expense 505,828 486,962 234,955 General & administrative expense - related party 160,664 200,609 - Total € 739,884 € 722,735 € 497,104 Unrecognized expense € 907,683 € 1,639,082 € - For the years ended December 31, 2023, 2022 and 2021, the Company recorded € 739,884 722,735 497,104 The amount of unrecognized expense at December 31, 2023 was € 907,683 1,639,082 1,088 no The weighted average grant date fair value of the options granted during the period ended December 31, 2023 and December 31, 2022 was € 4.84 4.99 Weighted average shares The calculation was performed by taking the number of shares outstanding during a given period and weighting them for the number of days that number of shares were outstanding. For the period ended December 31, 2023, and December 31, 2022, there was a weighted average of 18,216,907 18,216,858 no Quota B Valuations The fair value of the Quota B underlying the Company’s share-based compensation grants has historically been determined by the Company’s board of directors, with input from management and third-party valuations. The Company believes that the Board of Directors has the relevant experience and expertise to determine the fair value of its Quota B, when also securing third-party assistance. Given the absence of a public trading market of the Company’s equity, and in accordance with the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation, the Board of Directors exercised reasonable judgment and considered numerous objective and subjective factors to determine the best estimate of the fair value of the Company’s equity at each grant date. These factors include: ● valuations of the Quota B equity performed by third-party specialists; ● the price of the Company’s equity to third-party, arms-length, sophisticated, and qualified investors, which was used in the OPM Backsolve Model; ● the prices, rights, preferences, and privileges of the Company’s Quota C, D, and E preferred equity classes relative to those of the Company’s equity; ● lack of marketability of the Quota B; ● lack of voting rights of the Quota B; ● current business conditions and projections; ● hiring of key personnel and the experience of management; ● the Company’s stage of development; ● the timing, progress and results of the Company’s pre-clinical studies and clinical trials for the Company’s programs and product candidates; including statements regarding the timing of initiation and completion of trials or studies and related preparatory work, the period during which the results of the trials will become available and the Company’s research and development programs; ● likelihood of achieving a liquidity event, such as an initial public offering, a merger or acquisition of the Company given prevailing market conditions, or other liquidation events; ● the market performance of comparable publicly traded companies; and ● the European, U.S., and global capital market conditions. In valuing the Company’s Quota B class of options, the Board of Directors determined the equity value of the Company’s business using various valuation methods. The Board of Directors engaged a third-party valuation firm who performed analyses in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The Company’s option valuations were prepared using an option pricing method (“OPM”), which used market approaches to estimate the Company’s enterprise value. The OPM treats each equity class as a call option on the total equity value of a company, with exercise prices (i.e., breakpoints) based on the value thresholds at which the allocation among the various holders of a company’s securities changes. A discount was considered for Lack of Marketability (“DLOM”), which is an amount or percentage that is deducted from the value to reflect the absence of a viable market. The DLOM was then applied to arrive at an indication of value for the option. Also, considered in the valuation was volatility and the fact that the Quota B class of equity did not carry voting rights. The expected volatility used in the OPM is based upon the historical volatility of publicly traded companies in similar stages of clinical development. Application of the Company’s approach involved the use of estimates, judgment, and assumptions that are highly complex and subjective, such as those regarding the selection of comparable companies, and the expected timing of an IPO or other liquidity event. Changes in any or all of these estimates and assumptions or the relationships between those assumptions impact the valuations at each valuation date and may have a material impact on the valuation of the Company’s Quota B equity class, and consequently, the Company’s share-based compensation expense could be materially different. Weighted average shares As a result of the Company’s conversion to an S.P.A. in June 2021, the Company converted all its ownership to common shares. From that point forward, the Company was able to calculate both a weighted average and pro forma weighted average number of shares outstanding. The calculation was performed by taking the number of shares outstanding during a given period and weighting them for the number of days that number of shares were outstanding. Prior to June 2021, the Company was unable to convert quota to shares, in part due to the fact that quota carried different rights and privileges, so the Company was not sure how all quota would be treated in the conversion; however, shareholders agreed at the conversion in June 2021 that all classes of quota would be treated equally and all quota were exchanged for shares on a 1:1 basis and all the preferences were removed. Therefore, the Company was able to calculate a weighted average for the Company’s December 31, 2021 consolidated financial statement presentation. For the years ended December 31, 2023, 2022 and 2021 there was a weighted average of 18,216,907 18,216,858 15,083,825 |
Related parties
Related parties | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related parties | 13. Related parties The Company’s research and development expenses are a combination of third-party expenses, and related party expenses, as detailed below: Schedule of third party and related party expenses For the Year Ended December 31, 2023 Third Parties Related Parties Total (in Euros) Consultants & other third parties € 305,289 € 1,331,166 € 1,636,455 Materials & supplies 3,639,920 - 3,639,920 Compensation (including share-based) 467,557 645,932 1,113,489 Travel & entertainment 44,243 - 44,243 Other 39,965 369 40,334 Total € 4,496,974 € 1,977,467 € 6,474,441 For the Year Ended December 31, 2022 Third Parties Related Parties Total (in Euros) Consultants & other third parties € 804,341 € 726,082 € 1,530,423 Materials & supplies 2,790,982 - 2,790,982 Compensation (including share-based) 412,085 580,196 992,281 Other 25,276 - 25,276 Total € 4,032,684 € 1,306,278 € 5,338,962 For the Year Ended December 31, 2021 Third Parties Related Parties Total (in Euros) Consultants & other third parties € 946,156 € 711,464 € 1,657,620 Materials & supplies 1,231,019 - 1,231,019 Compensation (including share-based) 284,957 214,892 499,849 Travel & entertainment - 596 596 Other 1,593 - 1,593 Total € 2,463,725 € 926,952 € 3,390,677 Research and development (related party) expenses during the years ended December 31, 2023, 2022, and 2021, mainly relate to the clinical trial activity done as per the agreement with the OSR - San Raffaele Hospital. The increase in research and development expenses related parties for the year ended December 31, 2023, compared to the year ended December 31, 2022, was due to the increase in the number of treated patients and related clinical trial activities. Furthermore, the increase was also determined by the reduction in the offsetting effect of research and development tax credits. The Company recorded research and development expenses of approximately € 6.5 6.9 0.4 5.3 6.0 0.7 In 2021, the Company recorded research and development expenses of approximately € 3.4 4.6 1.2 The Company’s general and administrative expenses are also a combination of third-party and related party expenses, as detailed below: Schedule of third party and general and administrative expenses For the Year Ended December 31, 2023 Third Parties Related Parties Total (In Euros) Compensation (including share-based) € 1,218,299 € 1,317,068 € 2,535,367 Accounting, legal & other professional 1,026,534 - 1,026,534 Communication & IT related Facility 166,416 166,416 Facility & insurance related 6,180 15,731 21,911 Consultants & other third parties 610,103 - 610,103 Other 896,018 2,152 898,170 Total € 3,923,550 € 1,334,951 € 5,258,501 For the Year Ended December 31, 2022 Third Parties Related Parties Total (in Euros) Compensation (including share-based) € 1,293,880 € 1,268,974 € 2,562,854 Accounting, legal & other professional 781,817 - 781,817 Communication & IT related 171,380 - 171,380 Facility & insurance related 1,241,692 14,815 1,256,507 Consultants & other third parties 593,788 - 593,788 Other 331,824 6,860 338,684 Total € 4,414,381 € 1,290,649 € 5,705,030 For the Year Ended December 31, 2021 Third Parties Related Parties Total (in Euros) Compensation (including share-based) € 353,177 € 567,624 € 920,801 Accounting, legal & other professional 390,134 - 390,134 Communication & IT related 52,230 - 52,230 Facility & insurance related 71,181 14,399 85,580 Consultants & other third parties 675,688 - 675,688 Other 164,468 7,695 172,163 Total € 1,706,878 € 589,718 € 2,296,596 There were no significant changes in general and administrative expenses related parties during the year ended December 31, 2023, compared to the year ended December 31, 2022. General and administrative expenses, other than related party, decreased mainly because of the decrease in the Company’s limited liability insurance cost, aka director and officer (“D&O”) insurance. The increase in general and administrative expenses related parties during the year ended December 31, 2022, compared to the year ended December 31, 2021 was mainly due to the increase in management compensation. General and administrative expenses, other than related party, increased due to the increase in D&O insurance and to the increase in legal and audit fees as result of the post IPO administrative and compliance activities. The Company’s accounts payable to related parties are comprised as follows: Schedule of accounts payable to related parties 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) San Raffaele Hospital (OSR) € 170,888 € 150,206 € 25,047 Pierluigi Paracchi - - - Carlo Russo - 198 - Richard Slansky - 1,584 - Total € 170,888 € 151,988 € 25,047 The Company’s accrued expenses to related parties are comprised as follows: Schedule of accrued expenses to related parties 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) San Raffaele Hospital (OSR) € 413,935 € 176,559 € 19,201 Pierluigi Paracchi 175,254 112,501 25,000 Richard Slansky 116,738 81,369 53,502 Carlo Russo 155,651 118,778 34,438 Total € 861,578 € 489,207 € 132,141 The Company has identified the following related parties: ● Pierluigi Paracchi ● Luigi Naldini ● Bernhard Rudolph Gentner ● Carlo Russo ● Richard Slansky ● OSR - San Raffaele Hospital The following is a description of the nature of the transactions between the Company and these related parties: Pierluigi Paracchi Mr. Pierluigi Paracchi, President and Chairman of the Company prior to the conversion, is the current Chief Executive Officer, Vice-Chairman, as well as co-founder. His current employment arrangement with the Company provides an annual gross salary of € 420,000 40 In April 2022, Mr. Paracchi received a bonus of € 60,000 23,000 37,000 20 40 For the year ended December 31, 2023, and 2022, the Company expensed approximately € 692,000 624,000 At December 31, 2023 the Company accrued € 168,000 112,501 Luigi Naldini/Bernhard Rudolph Gentner Drs. Naldini and Gentner are co-founders of Genenta and part of the SAB – Scientific Advisory Board, with Dr. Naldini as Chairman, and Dr. Gentner as a member. Dr. Naldini has an advisory agreement approved by the Board of Directors and performs the pre-clinical studies for the Company. In particular, the pre- clinical experiments are in solid tumor indications. The last consulting agreement with Dr. Naldini was signed on June 20, 2022, which included an annual fee of € 100,000 100,000 Dr. Gentner, like Dr. Naldini, oversees pre-clinical research related to the platform technology. In addition, he analyzes clinical biological data. The last agreement with Dr. Gentner, started on July 1, 2022 and provided fees in the amount of € 45,000 45,000 Carlo Russo – former XDG Biomed LLC XDG Biomed is the LLC of Dr. Carlo Russo. Dr. Russo has a single contract signed by XDG and the Company that has been approved by the Board of Directors and was subject to multiple amendments. In particular, Dr. Russo, via XDG, served as the Company’s Chief Medical Officer and Head of Development. Dr. Russo is responsible for the clinical development of Temferon™, the Company’s gene therapy platform. The applicable recurring fees until the IPO date was € 300,000 50,000 500,000 30 For the year ended December 31, 2023, and 2022, the Company expensed approximately € 592,000 580,000 At December 31, 2023, the Company accrued approximately € 156,000 112,000 Richard Slansky Mr. Slansky is the Chief Financial Officer of the Company. Prior the IPO, he was engaged by the Company to assist with financial, accounting and audit support under an advisory agreement until the end of October 2021. On November 1, 2021, he joined the Company full time and has been employed as Chief Financial Officer. Under the new employment agreement, Mr. Slansky is entitled to receive a gross annual compensation of $ 300,000 30 375,000 30 For the year ended December 31, 2023, and 2022, the Company expensed approximately € 456,000 445,000 116,000 77,000 In July 2022, Mr. Slansky was awarded a stock option grant and part of it was immediately vested, with value accrued into the Company’s Consolidated Statements of Operations and Comprehensive Loss of approximately € 201,000 OSR – San Raffaele Hospital OSR - San Raffaele Hospital is a co-founder of the Company, and the Company is a corporate and research spin-off of OSR. OSR is one of the leading biomedical research institutions in Italy and Europe, with a 45-year history of developing innovative therapies and procedures. The Company has agreements to license technology, to perform research, pre-clinical and clinical activities, as well as to lease facilities and obtain certain other support functions. The Company’s headquarters is currently in an OSR facility. Amended and Restated OSR License Agreement The Company entered into an Amended and Restated License Agreement (the “ARLA”) with OSR in March 2023. The ARLA replaced the Company’s original license agreement originally entered into with OSR on December 15, 2014, as subsequently amended on March 16, 2017, February 1, 2019, December 23, 2020, September 28, 2021, January 22, 2022, September 29, 2022, and December 22, 2022 (the “Original OSR License Agreement”). The effectiveness of the ARLA was subject to Italy’s Law Decree No. 21 of March 15, 2012 (i.e., the Italian Golden Power regulations), as subsequently amended and supplemented, and would not become effective until the applicable Italian governmental authority consented to the ARLA. On April 20, 2023, such consent was received and the ARLA became effective. Pursuant to the terms of the ARLA, OSR has granted the Company an exclusive, royalty-bearing, non-transferrable (except with the prior written consent of OSR), sublicensable, worldwide license, subject to certain retained rights, to (1) certain patents, patent applications and existing know-how for the use in the field(s) of Interferon (“IFN”) gene therapy by lentiviral based-hematopoietic stem and progenitor cells (“HSPC”) gene transfer with respect to any solid cancer indication (including glioblastoma and solid liver cancer) and/or (b) any lympho-hematopoietic indication for which the Company exercises an option (described below); and (2) certain gene therapy products (subject to certain specified exceptions related to replication competent viruses) developed during the license term for use in the aforementioned field(s) consisting of any lentivirals or other viral vectors regulated by miR126 and/or miR130 and/or other miRs with the same expression pattern as miR126 and miR130 in hematopoietic cells for the expression of IFN under the control of a Tie2 promoter. Lympho-hematopoietic indication means any indication related to lympho-hematopoietic malignancies and solid cancer indication means any solid cancer indication (e.g., without limitation, breast, pancreas, colon cancer), with each affected human organ counting as a specific solid cancer indication. The rights retained by OSR, and extending to its affiliates, include the right to use the licensed technology for internal research within the field(s) of use, the right to use the licensed technology within the field(s) of use other than in relation to the licensed products, and the right to use the licensed technology for any use outside the field(s) of use, but subject to the options described below. In addition, the Company granted OSR a perpetual, worldwide, royalty-free, non-exclusive license to any improvement generated by the Company with respect to the licensed technology, to conduct internal research within the field(s) of use directly, or in or with the collaboration third parties; and, for any use outside the field(s) of use, in which case the license is sublicensable by OSR. Finally, the world-wide rights for the field(s) of use granted to the Company regarding the Lentigen know-how are non-exclusive and cannot be sublicensed due to a pre-existing nonexclusive sublicense to these rights between OSR and GlaxoSmithKline Intellectual Property Development Limited. Pursuant to the ARLA, the Company has an exclusive option exercisable until April 20, 2026 to any OSR product improvements at no additional cost, which could be useful for the development and/or commercialization of licensed products in the field of use. The Company also has an exclusive option exercisable until April 20, 2026 (the “LHI Option Period”) to any lympho-hematopoietic indication(s) to be included as part of the field of use, on an indication-by-indication basis, subject to the payment of specified option fees and milestone payments: ● € 1.0 ● € 0.5 ● € 0.3 No option fee is due for the fourth lympho-hematopoietic indication and any subsequent lympho-hematopoietic indications. The Company has the right to extend the LHI Option Period twice for additional 12-month periods, subject to the payment of specified extension fees. Prior to the effective date of the ARLA, the Company paid OSR an upfront fee in amount equal to € 250,000 Pursuant to the ARLA, as consideration, the Company agreed to pay OSR additional license fees equal to up to € 875,000 As part of the ARLA, the Company has agreed to use reasonable efforts to involve OSR in Phase I clinical trials for licensed products in the field of use, subject to OSR maintaining any required quality standards and providing its services on customary and reasonable terms and consistent with then-applicable market standards. We are also obligated to carry out our development activities using qualified and experienced professionals and sufficient level of resources. In particular, consistent with the terms of the Original OSR License Agreement, the ARLA continues to require us to invest (a) at least €5,425,000 with respect to the development of the licensed products, and (b) at least €2,420,000 with respect to the manufacturing of such licensed products (subject to certain adjustments) OSR maintains control of the preparation, prosecution and maintenance of the patents licensed. The Company is obligated to pay those costs unless additional licensees benefit from these rights, in which case the cost will be shared pro rata The ARLA expires upon the expiry of the “Royalty Term” for all licensed products and all countries, unless terminated earlier. The Royalty Term begins on the first commercial sale of a licensed product in each country, on a country by country basis, and ends upon the later of the (a) expiration of the commercial exclusivity for such product in that country (wherein the commercial exclusivity refers to any remaining valid licensed patent claims covering such licensed product, any remaining regulatory exclusivity to market and sell such licensed product or any remaining regulatory data exclusivity for such licensed product), and (b) 10 years from the first commercial sale of such licensed product in such country. The parties may terminate the agreement in the event the other party breaches its obligations therein, which termination shall become effective 60 business days following written notice thereof to the breaching party. The breaching party shall have the right to cure such breach or default during such 60 business days. OSR may terminate the agreement for failure to pay in the event that the Company fail to pay any of the upfront payment, additional license fees, sublicensing income or milestone payments within 30 days of due dates for each. In addition, OSR may terminate (with a 60-business-day prior written notice) the Company’s rights as to certain fields of use for the Company’s failure to achieve certain development milestones for specified licensed products within certain time periods, which may be subject to extension. In addition, OSR may terminate the agreement in the event that commercialization of a licensed product is not started within 24 months from the grant of both (i) the MAA approval and (ii) the pricing approval of such licensed product, provided that such termination will relate solely to such licensed product and to such country or region to which both such MAA approval and pricing approval were granted. Amendment to OSR Amended and Restated License Agreement On September 28, 2023, the Company and OSR entered into an amendment to the ARLA, whereby the Company and OSR agreed that the Company had fulfilled the obligations as set forth in the ARLA specific to Candidate Products 1 pursuant to the CP1 SRA. Furthermore, the amendment provides that the Company and OSR have no further obligations to negotiate and execute a sponsored research agreement for the performance of feasibility studies related to certain gene therapy products consisting of any lentiviral vectors regulated by miR126 and/or miR130 and/or other miRs with the same expression pattern as miR126 and miR130 in hematopoietic cells for the expression of cytokines and their variants (other than IFN or in addition to IFN) under the control of a Tie2 promoter, either alone or in combination with any immunotherapy (“Candidate Products 2”). Notwithstanding the removal of the obligation to enter into a sponsor research agreement with regards to Candidate Products 2, OSR granted the Company an exclusive option, to be exercised by sending written notice to OSR on or before September 30, 2025, to include certain intellectual property related to Candidate Products 2 and Candidate Products 2 as part of the licensed patents and licensed products under the ARLA. The option fee and the Company’s fee to extend the option period, if necessary, remain consistent with the prior fees to those costs reflected in the ARLA specific to Candidate Products 2. OSR will also have the right to prepare, file and prosecute patents and patent applications with respect to the results of Candidate Products 2. The amendment provides that the costs of the foregoing activities will be borne by the Company. At December 31, 2023, the cumulative total amount of expenses for the OSR clinical trial activity from inception amounted to approximately € 10.8 1.0 0.4 At December 31, 2023, there were no pending activities with OSR related to any agreement in place prior to the ARLA effective date, except for the project called “TEM-MM unspent budget reallocated to the TEM-GBM study”, for which the last tranche of activities corresponding to the 20% of the total project amounting to € 197,500 OSR Sponsor Research Agreement On August 1, 2023, the Company entered into a Sponsored Research Agreement (“CP1 SRA”), which was contemplated under the ARLA, pursuant to which the Company will fund feasibility studies for certain gene therapy products consisting of any lentiviral vectors regulated by miR126 and/or miR130 and/or other miRs with the same expression pattern as miR126 and miR130 in hematopoietic cells for the expression of IFN under the control of a Tie2 promoter, in combination with any immunotherapy (“Candidate Products 1”), along with three additional research projects, to be conducted at OSR. If OSR determines that additional funds are needed, OSR will inform the Company and provide an estimate for completing the research. During the period from the date of execution from the CP1 SRA until six months from the last report delivered to the Company under the CP1 SRA (the “CP1 Option Period”), the Company has the exclusive option to include certain intellectual property related to Candidate Products 1 and Candidate Products 1 as part of the licensed patents and licensed products under the ARLA. To exercise this option, the Company must pay an option exercise fee. The Company also has the right to extend the CP1 Option Period twice for additional 24-month periods. The extension requires payment of an extension fee for each 24-month extension. At December 31, 2023 the Company recorded and paid € 250,000 Operating leases The Company entered into a non-cancelable lease agreement for office space in January 2020 (see Note 14 below). |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | 14. Commitments and contingencies The Company exercises considerable judgment in determining the exposure to risks and recognizing provisions or providing disclosure for contingent liabilities related to pending litigations or other outstanding claims and liabilities. Judgment is necessary in assessing the likelihood that a pending claim will succeed, or a liability will arise and to quantify the possible range of the final settlement. Provisions are recorded for liabilities when losses are considered probable and can be reasonably estimated. Because of the inherent uncertainties in making such judgments, actual losses may be different from the originally estimated provision. Estimates are subject to change as new information becomes available, primarily with the support of internal specialists or outside consultants, such as actuaries or legal counsel. Adjustments to provisions may significantly affect future operating results. The following table summarizes the Company obligations by contractual maturity at December 31, 2023: Schedule of company obligations by contractual maturity (in Euros) Total Less than a year 1 to 3 years 4 to 5 years More than 5 years OSR operating leases and office rent 14,952 14,952 € - € - OSR - SRA ARLA 250,000 166,600 83,400 AGC manufacturing 234,754 209,704 25,050 - - Insurance policies 14,593 6,996 7,597 - - Total € 514,299 € 398,252 € 116,047 € - € - The commitments with OSR relate to the office rent agreement and the ARLA while the commitments with AGC Biologics (“AGC”) relate to product manufacturing and biologic stability studies on plasmid batches. Insurance on operating leases are related to the non-lease insurance component of the Company’s auto lease agreement, which was entered into in February 2022 and has a term of four (4) years. The Company has not included future milestone and royalty payments in the table above because the payment obligations under these agreements are contingent upon future events, such as the Company’s achievement of specified milestones or generating product sales, and the amount, timing and likelihood of such payments are unknown and are not yet considered probable. CMOs and CROs agreements The Company enters into contracts in the normal course of business with CMOs, CROs, and other third parties for exploratory studies, manufacturing, clinical trials, testing, and services (shipments, travel logistics, etc.). These contracts do not contain minimum purchase commitments and, except as discussed below, are cancelable by the Company upon prior written notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including non- cancelable obligations of the Company’s vendors or third-party service providers, up to the date of cancellation. These payments are not included in the table above as the amount and timing of such payments are not known. OSR - San Raffaele Hospital As part of the ARLA, the Company is obligated to carry out development activities using qualified and experienced professionals and sufficient level of resources. In particular, consistent with the terms of the Original OSR License Agreement, the ARLA continues to require us to invest (a) at least € 5,425,000 The Company incurred € 2.5 1.3 9.1 The Company has agreed to pay OSR royalties for 4 No events have occurred or have been achieved (and none are considered probable) to trigger any contingent payments under the ARLA during the period ended December 31, 2023. For information relating to the contingency payments or future milestones for these indications, please refer to Note 14 - Commitments and Contingencies. AGC Biologics The AGC agreement is non-cancelable, except in the case of breach of contract, and includes a potential milestone of € 0.3 0.5 1.0 0.5 1.0 In December 2021, the Company entered into Side Letter to the Framework Service Agreement with ACG Biologics to perform the manufacture of one (1) additional GMP 311,280 In March 2022, the Company entered into Side Letter to the Framework Service Agreement with ACG Biologics to perform the manufacture of one (1) additional GMP batch of 24L INFa LV vector (TIA-126 LV) completed in November 2022, for € 311,280 In October 2022, the Company entered into Side Letter to the Master Service Agreement dated March 6, 2019 to negotiate a technology transfer agreement regarding the transfer and implementation of the manufacturing process in the AGC facility located in Bresso, Italy, including timeline, budget and the technology transfer protocol (the “Tech Transfer”) and AGC agreed with the Company to procure raw materials to be use under the Tech Transfer. In December 2022, the Company signed respectively: (i) the Amendment No. 1 to the Master Service Agreement dated March 6, 2019 mainly to update the definition of raw materials; and (ii) a Process Transfer Agreement to agree on producing the raw materials necessary for the performance of the services related to the Tech Transfer for a total commitment of € 405,000 40,500 24,000 In January 2023, the Company entered into a new Development and Manufacturing Service Agreement providing the framework under which AGC will provide services pursuant to one or more work statements to be entered into from time to time during the agreement term. In February 2023, the Company entered into work statements (“SOW”) Nos. 1 and 2 to produce LVV for ex-vivo application (TIA-126-LV) for an estimated amount, including raw material and third party costs, of approximately € 0.7 1.5 0.6 In December 2023, the Company entered into purchase orders n. 41 and 42 under the Master Service Agreement dated March 6, 2019 as amended in December 2022, for e total amount of approximately € 0.2 Operating leases On December 1, 2019, the Company began a six-year non-cancelable (and renewable for further six (6) years) lease agreement for office space with OSR. Withdrawal is allowed from the fourth year with a notice of 12 months. Since the annual rent amounts to approximately € 15,000 15,000 Legal proceedings The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of ASC 450, Contingencies. |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent events | 15. Subsequent events The Company is not aware of any subsequent events. Subsequent events are events that occur after a company’s year-end period but before the release of the financial statements. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) for consolidated financial information and with the instructions to Form 20-F and Article 10 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to the authoritative US GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”), unless otherwise stated. A summary of the significant accounting policies applied in the preparation of these consolidated financial statements is presented below, only for the categories and headings now applicable and that might be applicable in the future based on the Company’s business. These policies have been consistently applied, unless otherwise stated. |
Principles of consolidation | Principles of consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. |
Use of estimates | Use of estimates The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts reported in the financial statements and the disclosures made in the accompanying notes. Estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses and related milestone payments, share-based compensation expense, valuation of Research & Development (“R&D”) tax credits, the valuation of equity and the recoverability of the Company’s net deferred tax assets and related valuation allowance. Estimates are periodically reviewed considering changes in circumstances, facts, and experience. Actual results may differ from these estimates under different assumptions or conditions. Changes in estimates are recorded in the period in which they become known. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed below. |
Cash and cash equivalents | Cash and cash equivalents The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents, which amounts may at times exceed federally insured limits. The Company has not experienced any losses on such accounts and does not believe it is exposed to any significant credit risk. In the consolidated cash flow statements, cash and cash equivalents include: cash on hand, deposits held with banks, and other short-term highly liquid investments. In the consolidated balance sheets, bank overdrafts, if any, are shown in current liabilities. Cash and cash equivalents are detailed as follows: Schedule of cash and cash equivalents 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) (Euro) Cash in bank € 3,687,402 € 29,790,838 € 37,236,089 Cash in hand & prepaid cards 4,018 4,018 4,073 Total € 3,691,420 € 29,794,856 € 37,240,162 |
Marketable securities | Marketable securities The Company’s marketable securities are maintained by investment managers and consist of highly rated foreign government debt securities. Debt securities are carried at fair value with the unrealized gains and losses included in other comprehensive income (loss) as a component of shareholders’ equity until realized. Any premium arising at purchase is amortized to the earliest call date and any discount arising at purchase is accreted to maturity. Amortization and accretion of premiums and discounts are recorded in interest income, net. Realized gains and losses on debt securities are determined using the specific identification method and are included in other income (expense), net. The Company classifies marketable securities with a remaining maturity when purchased of greater than three months as available-for-sale. Marketable securities with a remaining maturity date greater than one year are classified as non-current assets. Effective January 1, 2023, the Company adopted ASU 2016-13 , Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements The Company assesses its available-for-sale debt securities under the available-for-sale debt security impairment model in ASC 326 as of each reporting date in order to determine if a portion of any decline in fair value below carrying value recognized on its available-for-sale debt securities is the result of a credit loss. The Company records credit losses in the consolidated statements of operations and comprehensive loss as credit loss expense within other income (expense), net, which is limited to the difference between the fair value and the amortized cost of the security. To date, the Company has not recorded any credit losses on its available-for-sale debt securities. Accrued interest receivable related to the Company’s available-for-sale debt securities is presented within receivables and other current assets on the Company’s consolidated balance sheets. The Company has elected the practical expedient available to exclude accrued interest receivable from both the fair value and the amortized cost basis of available-for-sale debt securities for the purposes of identifying and measuring any impairment. The Company writes off accrued interest receivable once it has determined that the asset is not realizable. Any write offs of accrued interest receivable are recorded by reversing interest income, recognizing credit loss expense, or a combination of both. To date, the Company has not written off any accrued interest receivables associated with its marketable securities. The unrealized gain recognized during the reporting period on marketable securities still held at the report date was approximately € 268,000 53,000 |
Net loss and comprehensive income (loss) | Net loss and comprehensive income (loss) Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. ASC 220 Comprehensive Income requires that an entity records all components of comprehensive (loss) income, net of their related tax effects, in its financial statements in the period in which they are recognized. For the years ended December 31, 2023, net loss was € 11.6 199,131 11.4 |
Net loss per share | Net loss per share Net loss per share (“EPS”) is computed in accordance with US GAAP. Basic EPS is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted EPS reflects potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period increased by the number of additional common shares that would have been outstanding if all potential common shares had been issued and were dilutive. The EPS calculation was applied at the Company conversion to S.p.A. in June 2021, after the increase in capital to € 50,000 59.7 100 18,216,958 2.7 At December 31, 2023, the Company had 382,785 23,502 382,785 23,502 |
Foreign currency translation | Foreign currency translation The reporting and functional currency of the Company is Euros. All amounts are presented in Euros unless otherwise stated. All amounts disclosed in the consolidated financial statements and notes have been rounded to the nearest Euro unless otherwise stated. Foreign currency transactions, if any, are translated into Euros using the exchange rates prevailing at the date(s) of the transaction(s) or valuation where items are re-measured. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statements of operations. For financial reporting purposes, the assets and liabilities of the U.S. Subsidiary are translated into EUR using exchange rates in effect at the balance sheet date. The net income/(loss) of the U.S. Subsidiary is translated into EUR using average exchange rates in effect during the reporting period. The resulting currency translation impact is recorded in Shareholders’ equity as a cumulative translation adjustment. For 2023, the currency translation impact was approximately € 15,800 0.2 The net exchange gain was approximately € 2.3 1.6 12.0 0.4 0.3 |
Emerging growth company status | Emerging growth company status The Company is an “emerging growth company,” as defined in the U.S. Jumpstart Our Business Startups Act, or U.S. JOBS Act, and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. The Company may take advantage of these exemptions until the Company is no longer an “emerging growth company.” Section 107 of the U.S. JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period afforded by the U.S. JOBS Act for the implementation of new or revised accounting standards. The Company has elected to use the extended transition period for complying with new or revised accounting standards and, because of this election, its consolidated financial statements may not be comparable to companies that comply with public company effective dates. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of its initial public offering (“IPO”) or such earlier time that it is no longer an “emerging growth company.” |
Fair value measurements | Fair value measurements Certain assets and liabilities of the Company are carried at fair value under US GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1 — Quoted prices in active markets for identical assets or liabilities. ● Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying values of the Company’s R&D tax credits, VAT credits, accounts payable, accrued expenses and other current liabilities were evaluated and determined to approximate their fair values due to the short-term nature of these assets and liabilities. Schedule of fair values due to short-term nature of assets and liabilities Total Level 1 Level 2 Level 3 December 31, 2023 Total Level 1 Level 2 Level 3 Cash and cash equivalents € 3,691,420 3,691,420 € - € - Marketable Securities 15,084,284 15,084,284 - - Total financial assets € 18,775,704 € 18,775,704 € - € - Total Level 1 Level 2 Level 3 December 31, 2022 Total Level 1 Level 2 Level 3 Cash and cash equivalents € 29,794,856 29,794,856 € - € - Total financial assets € 29,794,856 € 29,794,856 € - € - Total Level 1 Level 2 Level 3 December 31, 2021 Total Level 1 Level 2 Level 3 Cash and cash equivalents € 37,240,162 37,240,162 € - € - Total financial assets € 37,240,162 € 37,240,162 € - € - |
Segment information | Segment information Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company and its chief operating decision-maker view the Company’s operations and manages its business in one operating segment, which is the research and development in the pharmaceutical sector with a focus on developing novel therapeutics to treat cancer. |
Tax credit on investments in research and development | Tax credit on investments in research and development In line with the legislation in force at December 31, 2023, and 2022, companies in Italy that invest in eligible research and development activities, regardless of the legal form and economic sector in which they operate, can benefit from a tax credit which can be used in order to reduce most taxes payable, including income tax or regional tax on productive activities, as well as social security contributions and payroll withholding taxes. For eligible research and development activities, the tax credit was equal to 20% in fiscal year 2022 (“FY 2022”) of the eligible costs incurred, with a maximum annual amount of € 4.0 5.0 The eligible activities consist of fundamental research, industrial research, and experimental development as defined respectively of the letters m), q) and j) of point 15, par. 1.3 of the Communication no. 198/2014 of the European Commission. To determine the cost basis of the benefit, the following expenses are eligible: ● Personnel costs; ● Depreciation charges, costs of the financial or simple lease and other expenses related to movable tangible assets and software used in research and development projects; ● Expenses for extra-euro research contracts concerning the direct execution of eligible research and development activities by the provider; ● Depreciation charges; ● Expenses for consulting services and equivalent services related to eligible research and development activities; and, ● Expenses for materials, supplies, and other similar products used in research and development projects. The Company, by analogy, accounts for this receivable in accordance with International Accounting Standards (IAS) 20, Accounting for Government Grants and Disclosure of Government Assistance While these tax credits can be carried forward indefinitely, the Company recognized an amount which reflects management’s best estimate of the amount that is reasonably assured to be realized or utilized in the foreseeable future based on historical benefits realized, adjusted for expected changes, as applicable. The tax credits are recorded as an offset to research and development expenses in the Company’s Consolidated Statements of Operations and Comprehensive Loss . |
Share-based compensation | Share-based compensation To reward the efforts of employees, directors, and certain consultants and to promote the growth of the Company, the Company’s Board of Directors has approved, prior to the Company’s conversion to an S.p.A., various share-based awards. All options have been awarded with an exercise price of €1 per quota and, when exercised, all options have been converted to Quota B. The options granted had the vesting condition that the individual must remain in his/her role at least one year or as otherwise specified for each person. In May 2021, the Company’s quotaholders adopted the Company’s “Equity Incentive Plan 2021–2025” (“the Plan”); however, through December 31, 2021, no options or awards were granted and there were no outstanding options or awards. (See Note 12. Share-based compensation.) In April 2022, the Company’s board of directors, as administrator of the Plan, awarded nonqualified stock options (“NSOs”) on 147,783 In July 2022, the Company’s board of directors, as administrator of the Plan, awarded NSOs on 392,740 In March 2023, the board of directors, as administrator of the Plan, awarded NSOs on 46,400 In June 2023, the Company’s shareholders modified the Plan to extend the final deadline for the issuance of the ordinary shares until December 31, 2035, in order to allow that all stock options granted during the term of the Plan could provide for an exercise period of 10 years starting from the date of grant. (See Note 12. Share-based compensation.) Currently, the Company has authorized options on 1,821,695 10 18,216,958 2,700,000 2,700,000 27,000,000 586,923 1,234,772 The Company measures its stock option awards granted to employees, officers, directors, and consultants under the Plan based on their fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is normally 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. The Company classifies stock-based compensation expense in its Consolidated Statement of Operations and Comprehensive Loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. The Company chose the Black-Scholes-Merton model because it is considered easier to apply and also it is a defined equation and incorporates only one set of inputs. As a result, it is the model most commonly in use. |
Representative warrants | Representative warrants The Company agreed to issue warrants to the underwriters of the IPO (“Warrants”) to purchase 23,502 14.375 The Warrants will provide for adjustment in the number and price of the Warrants and the ADSs underlying such Warrants in the event of recapitalization, merger, stock split or other structural transaction, or a future financing undertaken by the Company. The Warrants were evaluated under applicable guidance and accordingly classified as equity in the consolidated financial statements. |
Non-current assets right of use (ROU) | Non-current assets right of use (ROU) Upon commencement of a contract containing a lease, the Company classifies leases other than short-term leases as either an operating lease or a finance lease according to the criteria prescribed by ASC 842. The Company recognizes both lease liabilities and right-of-use assets on the balance sheet for all leases, except for short-term leases (those with a lease term of 12 months or less). Lease liabilities are initially measured at the present value of the future lease payments over the lease term, discounted at the rate implicit in the lease or, if that rate is not readily determinable, the Company’s incremental borrowing rate. The right-of-use assets represent the lessee’s right to use the underlying asset for the lease term and are initially measured at the same amount as the corresponding lease liability. For finance leases, the Company recognizes interest expense on the lease liability and amortization expense on the right-of-use asset. For operating leases, lease expense is recognized on a straight-line basis over the lease term. |
Fixed Assets | Fixed Assets Property and equipment are stated at cost, including any accessory and direct costs that are necessary to make the assets fit for use, and adjusted by the corresponding accumulated depreciation. Depreciation is systematically recorded in the consolidated financial statements taking into consideration the use, purpose, and financial-technical duration of the assets, based on their estimated useful economic lives. Leasehold improvements depreciation is recorded based on the shorter of the life of the leasehold improvement or the remaining term of the lease. Ordinary maintenance costs are expensed to the Consolidated Statements of Operations and Comprehensive Loss in the year in which they are incurred. Extraordinary maintenance costs, the purpose of which is to extend the useful economic life of the asset, to technologically upgrade it and/or to increase its productivity or safety for the purpose of economic productivity of the Company, are attributed to the asset to which they refer and depreciated on the basis of its estimated useful economic life. Amortization of leasehold improvements is computed using the straight-line method based upon the terms of the applicable lease or estimated useful life of the improvements, whichever is less. |
Impairment of long-lived assets | Impairment of long-lived assets In accordance with ASC Topic 360-10-20, “Property, Plant and Equipment,” the Company performs an impairment test whenever events or circumstances indicate that the carrying value of long- lived assets with finite lives may be impaired. Impairment is measured by comparing the carrying value of the long-lived assets to the estimated undiscounted pre-tax cash flows expected to result from the use of such assets and their ultimate disposition. In circumstances where impairment is determined to exist, the Company will write down the asset to its fair value based on the present value of estimated cash flows. To date, no impairments have been identified for the periods ended December 31, 2023, and 2022. |
Deferred offering costs | Deferred offering costs Deferred public offering costs, which primarily consist of direct, incremental legal and accounting fees relating to fundraising activities (e.g., an IPO), were capitalized within prepaid expenses and other current assets prior to the IPO and netted or offset with the IPO proceeds upon closing of the IPO. For the year ended December 31, 2023, the Company incurred approximately € 0.3 For the year ended December 31, 2022, the Company did not incur offering costs. For the year ended December 31, 2021, the Company incurred approximately € 3.9 156,000 |
Recently issued accounting pronouncements | Recently issued accounting pronouncements In April 2012, the U.S. Jump-Start Our Business Startups Act (the “U.S. JOBS Act”) was signed into law. The U.S. JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company may elect to adopt new or revised accounting standards when they become effective for non-public companies, which typically is later than when public companies must adopt the standards. The Company has elected to take advantage of the extended transition period afforded by the U.S. JOBS Act and, as a result, unless the Company elects early adoption of any standards, will adopt the new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-public companies. In December 2019, the FASB issued ASU 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes. The new standard intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intra-period tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. For non-public entities, the standard is effective for annual periods beginning after December 15, 2021, with early adoption permitted. Adoption of the standard requires certain changes to primarily be made prospectively, with some changes to be made retrospectively. The Company is currently evaluating the impact that the adoption of ASU 2019-12 will have on its consolidated financial statements. In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance. The aim of ASU 2021-10 is to increase the transparency of government assistance including the disclosure of (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on an entity’s financial statements. Diversity currently exists in the recognition, measurement, presentation, and disclosure of government assistance received by business entities because of the lack of specific authoritative guidance in GAAP. The ASU will be effective for annual reporting periods after December 15, 2021, and early adoption is permitted. Upon implementation, the Company may use either a prospective or retrospective method of adoption when adopting the ASU. The Company is evaluating the impact of adopting the new ASU. In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging —Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This ASU amends the guidance on convertible instruments and the derivatives scope exception for contracts in an entity’s own equity and improves and amends the related EPS guidance for both Subtopics. The ASU will be effective for annual reporting periods after December 15, 2023, and interim periods within those annual periods and early adoption is permitted in fiscal periods ending after December 15, 2020. Upon implementation, the Company may use either a modified retrospective or full retrospective method of adoption. The Company is evaluating the impact of adopting the new ASU. |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of cash and cash equivalents | Schedule of cash and cash equivalents 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) (Euro) Cash in bank € 3,687,402 € 29,790,838 € 37,236,089 Cash in hand & prepaid cards 4,018 4,018 4,073 Total € 3,691,420 € 29,794,856 € 37,240,162 |
Schedule of fair values due to short-term nature of assets and liabilities | The carrying values of the Company’s R&D tax credits, VAT credits, accounts payable, accrued expenses and other current liabilities were evaluated and determined to approximate their fair values due to the short-term nature of these assets and liabilities. Schedule of fair values due to short-term nature of assets and liabilities Total Level 1 Level 2 Level 3 December 31, 2023 Total Level 1 Level 2 Level 3 Cash and cash equivalents € 3,691,420 3,691,420 € - € - Marketable Securities 15,084,284 15,084,284 - - Total financial assets € 18,775,704 € 18,775,704 € - € - Total Level 1 Level 2 Level 3 December 31, 2022 Total Level 1 Level 2 Level 3 Cash and cash equivalents € 29,794,856 29,794,856 € - € - Total financial assets € 29,794,856 € 29,794,856 € - € - Total Level 1 Level 2 Level 3 December 31, 2021 Total Level 1 Level 2 Level 3 Cash and cash equivalents € 37,240,162 37,240,162 € - € - Total financial assets € 37,240,162 € 37,240,162 € - € - |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of effective income tax rate reconciliation | The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. A reconciliation of the Company’s effective tax rate is summarized as follows: Schedule of effective income tax rate reconciliation 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) Income taxes at Italy statutory rate € (2,794,909 ) € (2,034,663 ) € (1,296,797 ) Permanent differences 309,512 (160,133 ) (1,189,844 ) Other (171,032 ) 715 (29,928 ) Federal Income tax for Genenta INC (89,910 ) (31,993 ) (26,462 ) Change in valuation allowance 2,746,339 2,226,074 2,543,031 Total provision expense for income taxes € - € - € - |
Schedule of deferred tax assets | Significant components of the Company’s net deferred tax assets are summarized as follows: Schedule of deferred tax assets 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) Deferred tax assets Net operating loss carryforwards € 11,772,870 € 9,197,563 € 7,125,174 Other temporary differences 150,347 52,996 6,000 Allowance for corporate equity 495,692 422,011 315,322 Total deferred tax assets 12,418,909 9,672,570 7,446,496 Valuation allowance (12,418,909 ) (9,672,570 ) (7,446,496 ) Net deferred tax assets € - € - € - |
Schedule of tax loss carryforwards expire | Schedule of tax loss carryforwards expire 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) No expiration date € 5,487,085 € 5,487,085 € 5,487,085 No expiration date - DL 98/2011 43,191,915 33,054,966 24,241,891 Total € 48,679,000 € 38,542,051 € 29,728,976 |
Prepaid expenses and other cu_2
Prepaid expenses and other current assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consist of the following: Schedule of prepaid expenses and other current assets 2023 2022 2021 At December 31, 2023 2022 2021 (Euro) Value Added Tax (VAT) € 1,170,634 € 912,423 € 820,780 Research and development tax credit 833,000 650,000 600,000 Advances payments to suppliers 34,108 41,149 58,009 Other current assets 64,664 219,400 21,987 Other prepaids 378,148 103,540 18,247 Total € 2,480,554 € 1,926,512 € 1,519,023 |
Fixed assets, net (Tables)
Fixed assets, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of fixed assets,net | Fixed assets consist of the following: Schedule of fixed assets,net 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) Software (ERP Implementation) € 87,800 € 87,800 € - Computer 35,971 31,307 24,869 Furniture and fixtures 13,005 4,676 5,010 Total fixed assets 136,776 123,783 29,879 Less: accumulated depreciation (53,799 ) (12,144 ) (6,789 ) Fixed assets, net € 82,977 € 111,639 € 23,090 |
Other non-current assets (Table
Other non-current assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of other non-current assets | Other non-current assets consist of the long-term portion of the VAT receivable and R&D tax credit, as follows: Schedule of other non-current assets 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) Value Added Tax (VAT) € 630,342 € 912,424 € 641,215 Research and development tax credit 167,000 650,000 600,000 Other non-current assets 207,218 39,079 Total other non-current assets € 1,004,560 € 1,601,503 € 1,241,215 |
Quotaholders_ and shareholder_2
Quotaholders’ and shareholders’ equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of equity method investment and ownership percentage | The Company’s capital was divided between five (5)categories of quotas as summarized below at January 1, 2021: Schedule of equity method investment and ownership percentage At January 1, Ownership Quota 2021 % A € 10,458 28 % B 6,886 19 % C 8,645 23 % D 4,034 11 % E 7,033 19 % Total € 37,056 100 % |
Share-based compensation (Table
Share-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Outstanding Stock Options | Schedule of Outstanding Stock Options Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding as of January 1, 2021 546 € 1.00 1 € 584,132 Granted 169 1.00 - 183,831 Vested and exercised 715 1.00 - 777,920 Cancelled or forfeited - - - - Outstanding as of December 31, 2021 - € - - € - Exercisable as of December 31, 2021 - € - - € - Outstanding, expected to vest as of December 31, 2021 - € - - € - Outstanding as of January 1, 2022 - - - - Granted 540,523 € 4.99 7.3 € 272,480 Vested and exercised - - - - Cancelled or forfeited - - - - Outstanding as of December 31, 2022 540,523 € 4.99 7.3 € 272,480 Exercisable as of December 31, 2022 237,129 € 5.66 4.42 € 61,988 Outstanding, expected to vest as of December 31, 2022 303,394 € 4.67 9.55 € 210,492 Outstanding as of January 1, 2023 540,523 € 4.99 7.3 € 272,480 Granted 46,400 5.30 9.17 - Vested and exercised - - - - Cancelled or forfeited - - - - Outstanding as of December 31, 2023 586,923 € 4.84 6.53 € 67,596 Exercisable as of December 31, 2023 382,785 € 5.11 5.44 € 33,796 Outstanding, expected to vest as of December 31, 2023 204,138 € 4.34 8.58 € 33,800 |
Schedule of share based compensation expenses | The Company’s share-based compensation expense for the years ended December 31, 2023, 2022 and 2021 is represented by the following table: Schedule of share based compensation expenses 2023 2022 2021 Year ended December 31 2023 2022 2021 (in Euros) Research & development expense € 73,392 € 35,164 € 82,669 Research & development expense - related party - - 179,480 General & administrative expense 505,828 486,962 234,955 General & administrative expense - related party 160,664 200,609 - Total € 739,884 € 722,735 € 497,104 Unrecognized expense € 907,683 € 1,639,082 € - |
Related parties (Tables)
Related parties (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Schedule of accounts payable to related parties | The Company’s accounts payable to related parties are comprised as follows: Schedule of accounts payable to related parties 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) San Raffaele Hospital (OSR) € 170,888 € 150,206 € 25,047 Pierluigi Paracchi - - - Carlo Russo - 198 - Richard Slansky - 1,584 - Total € 170,888 € 151,988 € 25,047 |
Schedule of accrued expenses to related parties | The Company’s accrued expenses to related parties are comprised as follows: Schedule of accrued expenses to related parties 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) San Raffaele Hospital (OSR) € 413,935 € 176,559 € 19,201 Pierluigi Paracchi 175,254 112,501 25,000 Richard Slansky 116,738 81,369 53,502 Carlo Russo 155,651 118,778 34,438 Total € 861,578 € 489,207 € 132,141 |
Research and Development Expense [Member] | |
Schedule of third party and general and administrative expenses | The Company’s research and development expenses are a combination of third-party expenses, and related party expenses, as detailed below: Schedule of third party and related party expenses For the Year Ended December 31, 2023 Third Parties Related Parties Total (in Euros) Consultants & other third parties € 305,289 € 1,331,166 € 1,636,455 Materials & supplies 3,639,920 - 3,639,920 Compensation (including share-based) 467,557 645,932 1,113,489 Travel & entertainment 44,243 - 44,243 Other 39,965 369 40,334 Total € 4,496,974 € 1,977,467 € 6,474,441 For the Year Ended December 31, 2022 Third Parties Related Parties Total (in Euros) Consultants & other third parties € 804,341 € 726,082 € 1,530,423 Materials & supplies 2,790,982 - 2,790,982 Compensation (including share-based) 412,085 580,196 992,281 Other 25,276 - 25,276 Total € 4,032,684 € 1,306,278 € 5,338,962 For the Year Ended December 31, 2021 Third Parties Related Parties Total (in Euros) Consultants & other third parties € 946,156 € 711,464 € 1,657,620 Materials & supplies 1,231,019 - 1,231,019 Compensation (including share-based) 284,957 214,892 499,849 Travel & entertainment - 596 596 Other 1,593 - 1,593 Total € 2,463,725 € 926,952 € 3,390,677 |
General and Administrative Expense [Member] | |
Schedule of third party and general and administrative expenses | The Company’s general and administrative expenses are also a combination of third-party and related party expenses, as detailed below: Schedule of third party and general and administrative expenses For the Year Ended December 31, 2023 Third Parties Related Parties Total (In Euros) Compensation (including share-based) € 1,218,299 € 1,317,068 € 2,535,367 Accounting, legal & other professional 1,026,534 - 1,026,534 Communication & IT related Facility 166,416 166,416 Facility & insurance related 6,180 15,731 21,911 Consultants & other third parties 610,103 - 610,103 Other 896,018 2,152 898,170 Total € 3,923,550 € 1,334,951 € 5,258,501 For the Year Ended December 31, 2022 Third Parties Related Parties Total (in Euros) Compensation (including share-based) € 1,293,880 € 1,268,974 € 2,562,854 Accounting, legal & other professional 781,817 - 781,817 Communication & IT related 171,380 - 171,380 Facility & insurance related 1,241,692 14,815 1,256,507 Consultants & other third parties 593,788 - 593,788 Other 331,824 6,860 338,684 Total € 4,414,381 € 1,290,649 € 5,705,030 For the Year Ended December 31, 2021 Third Parties Related Parties Total (in Euros) Compensation (including share-based) € 353,177 € 567,624 € 920,801 Accounting, legal & other professional 390,134 - 390,134 Communication & IT related 52,230 - 52,230 Facility & insurance related 71,181 14,399 85,580 Consultants & other third parties 675,688 - 675,688 Other 164,468 7,695 172,163 Total € 1,706,878 € 589,718 € 2,296,596 |
Commitments and contingencies (
Commitments and contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of company obligations by contractual maturity | The following table summarizes the Company obligations by contractual maturity at December 31, 2023: Schedule of company obligations by contractual maturity (in Euros) Total Less than a year 1 to 3 years 4 to 5 years More than 5 years OSR operating leases and office rent 14,952 14,952 € - € - OSR - SRA ARLA 250,000 166,600 83,400 AGC manufacturing 234,754 209,704 25,050 - - Insurance policies 14,593 6,996 7,597 - - Total € 514,299 € 398,252 € 116,047 € - € - |
Nature of business and history
Nature of business and history (Details Narrative) - EUR (€) | 1 Months Ended | 12 Months Ended | ||||||
May 12, 2023 | Dec. 27, 2021 | Dec. 15, 2021 | May 20, 2021 | Jul. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Conversion of stock, shares issued | 15,000,000 | |||||||
Number of ordinary shares issued | 100 | |||||||
Number of ordinary shares subscribed | 720,114 | |||||||
American depository shares | 2,400,000 | |||||||
Number of shares outstanding | 18,216,958 | 18,216,858 | 18,216,858 | |||||
Net listing costs | € 3,900,000 | |||||||
Gross sale proceeds | € 100,000,000 | |||||||
Net loss | € 11,645,455 | € 8,477,763 | € 5,529,332 | |||||
Accumulated deficit | 47,143,025 | 35,465,559 | 27,019,807 | |||||
Cash and cash equivalents and marketable securities | 18,800,000 | |||||||
Cash | 3,691,420 | € 29,794,856 | € 37,240,162 | |||||
Marketable securities | 15,100,000 | |||||||
Unrealized net loss from exchange rate | € 200,000 | |||||||
Sales Agreement [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Gross proceeds | € 639 | |||||||
Shares outstanding | 18,216,958 | |||||||
IPO [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of ordinary shares issued | 3,120,114 | |||||||
Net listing costs | € 29,000,000 | |||||||
Over-Allotment Option [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
American depository shares | 96,744 |
Schedule of cash and cash equiv
Schedule of cash and cash equivalents (Details) - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | |||
Cash in bank | € 3,687,402 | € 29,790,838 | € 37,236,089 |
Cash in hand & prepaid cards | 4,018 | 4,018 | 4,073 |
Total | € 3,691,420 | € 29,794,856 | € 37,240,162 |
Schedule of fair values due to
Schedule of fair values due to short-term nature of assets and liabilities (Details) - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Platform Operator, Crypto-Asset [Line Items] | |||
Cash and cash equivalents | € 3,691,420 | € 29,794,856 | € 37,240,162 |
Marketable Securities | 15,084,284 | ||
Total financial assets | 18,775,704 | 29,794,856 | 37,240,162 |
Fair Value, Inputs, Level 1 [Member] | |||
Platform Operator, Crypto-Asset [Line Items] | |||
Cash and cash equivalents | 3,691,420 | 29,794,856 | 37,240,162 |
Marketable Securities | 15,084,284 | ||
Total financial assets | 18,775,704 | 29,794,856 | 37,240,162 |
Fair Value, Inputs, Level 2 [Member] | |||
Platform Operator, Crypto-Asset [Line Items] | |||
Cash and cash equivalents | |||
Marketable Securities | |||
Total financial assets | |||
Fair Value, Inputs, Level 3 [Member] | |||
Platform Operator, Crypto-Asset [Line Items] | |||
Cash and cash equivalents | |||
Marketable Securities | |||
Total financial assets |
Summary of significant accoun_4
Summary of significant accounting policies (Details Narrative) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||||||||
Dec. 15, 2021 shares | May 20, 2021 shares | Jul. 31, 2023 shares | Mar. 31, 2023 shares | Jul. 31, 2022 shares | Apr. 30, 2022 shares | May 31, 2021 | Dec. 31, 2023 EUR (€) shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2022 EUR (€) | Dec. 31, 2021 EUR (€) shares | Dec. 31, 2020 shares | |
Property, Plant and Equipment [Line Items] | ||||||||||||
Unrealized gain | € | € 268,000 | |||||||||||
Unrealized gain | € | 53,000 | |||||||||||
Net loss | € | 11,645,455 | € 8,477,763 | € 5,529,332 | |||||||||
Other comprehensive income | € | 199,131 | |||||||||||
Comprehensive loss | € | € 11,446,324 | 8,477,763 | € 5,529,332 | |||||||||
Stockholders' Equity, Period Increase (Decrease) | € | 50,000 | |||||||||||
Common Stock, Shares Authorized | shares | 59,700,000 | 59,700,000 | ||||||||||
Number of warrants issued to the underwriters | shares | 100 | |||||||||||
Common Stock, Shares, Outstanding | shares | 18,216,958 | 18,216,858 | 18,216,858 | |||||||||
Number of shares outstanding | shares | 586,923 | 540,523 | 546 | |||||||||
Impact of foreign currency translation | € | € 15,800 | |||||||||||
Netincomeloss | € | 200,000 | |||||||||||
Net exchange gain | € | (216,891) | 2,286,690 | ||||||||||
Net exchange gain realized | € | 1,600,000 | |||||||||||
Tax credit on investments in research and development, annual amount | € | € 4,100,000 | 4,400,000 | ||||||||||
Number of shares awarded | shares | 46,400 | 392,740 | 147,783 | |||||||||
Number of shares outstanding, percentage | 10% | |||||||||||
Number of options available for grant | shares | 1,234,772 | 1,281,162 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 14.375 | |||||||||||
Common Stock [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Net loss | € | ||||||||||||
Number of shares outstanding | shares | 586,923 | |||||||||||
Number of shares outstanding | shares | 18,216,958 | 18,216,858 | 18,216,858 | |||||||||
Minimum [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Tax credit on investments in research and development, annual amount | € | € 4,000,000 | 5,000,000 | ||||||||||
Maximum [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Tax credit on investments in research and development, annual amount | € | € 5,000,000 | |||||||||||
Maximum [Member] | Common Stock [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Share-based payment award, options, number of shares, period increase | shares | 2,700,000 | |||||||||||
Number of options available for grant | shares | 2,700,000 | |||||||||||
Number of shares outstanding | shares | 27,000,000 | |||||||||||
US$ Trade Payables [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Net exchange gain realized | € | 400,000 | |||||||||||
US$ Time Deposits [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Net exchange loss unrealized | € | € 300,000 | |||||||||||
IPO [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Number of warrants issued to the underwriters | shares | 3,120,114 | |||||||||||
Net exchange gain realized | $ | $ 12 | |||||||||||
Number of stock issued, value | € | € 3,900,000 | |||||||||||
Deferred offering costs | € | € 156,000 | |||||||||||
ATM Offering Costs [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Number of stock issued, value | € | € 300,000 | |||||||||||
Share-Based Payment Arrangement, Option [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | shares | 382,785 | |||||||||||
Share-Based Payment Arrangement, Option [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Number of shares outstanding | shares | 382,785 | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Common Stock [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Number of shares outstanding | shares | 18,216,958 | |||||||||||
Number of shares authorized | shares | 1,821,695 | |||||||||||
Number of shares outstanding, percentage | 10% | |||||||||||
Underswriters Common Share Warrants [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Number of shares outstanding | shares | 23,502 | |||||||||||
Underswriters Warrants [Member] | IPO [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Number of warrants issued to the underwriters | shares | 23,502 | |||||||||||
Equity Incentive Plan 2021 - 2025 [Member] | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | shares | 2,700,000 |
Schedule of effective income ta
Schedule of effective income tax rate reconciliation (Details) - EUR (€) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Income taxes at Italy statutory rate | € (2,794,909) | € (2,034,663) | € (1,296,797) |
Permanent differences | 309,512 | (160,133) | (1,189,844) |
Other | (171,032) | 715 | (29,928) |
Federal Income tax for Genenta INC | (89,910) | (31,993) | (26,462) |
Change in valuation allowance | 2,746,339 | 2,226,074 | 2,543,031 |
Total provision expense for income taxes |
Schedule of deferred tax assets
Schedule of deferred tax assets (Details) - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | |||
Net operating loss carryforwards | € 11,772,870 | € 9,197,563 | € 7,125,174 |
Other temporary differences | 150,347 | 52,996 | 6,000 |
Allowance for corporate equity | 495,692 | 422,011 | 315,322 |
Total deferred tax assets | 12,418,909 | 9,672,570 | 7,446,496 |
Valuation allowance | (12,418,909) | (9,672,570) | (7,446,496) |
Net deferred tax assets |
Schedule of tax loss carryforwa
Schedule of tax loss carryforwards expire (Details) - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Operating Loss Carryforwards [Line Items] | |||
Total | € 48,679,000 | € 38,542,051 | € 29,728,976 |
No Expiration Date [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Total | 5,487,085 | 5,487,085 | 5,487,085 |
No Expiration Date - DL 98/2011 [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Total | € 43,191,915 | € 33,054,966 | € 24,241,891 |
Income taxes (Details Narrative
Income taxes (Details Narrative) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Percentage of taxable income can off-set | 80% |
Schedule of prepaid expenses an
Schedule of prepaid expenses and other current assets (Details) - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||
Value Added Tax (VAT) | € 1,170,634 | € 912,423 | € 820,780 |
Research and development tax credit | 833,000 | 650,000 | 600,000 |
Advances payments to suppliers | 34,108 | 41,149 | 58,009 |
Other current assets | 64,664 | 219,400 | 21,987 |
Other prepaids | 378,148 | 103,540 | 18,247 |
Total | € 2,480,554 | € 1,926,512 | € 1,519,023 |
Prepaid expenses and other cu_3
Prepaid expenses and other current assets (Details Narrative) - EUR (€) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |||
Percentage of value added tax | 22% | 22% | |
Research and development tax credit | € 4,100,000 | € 4,400,000 | |
Taxes payable current | 732,000 | 600,000 | |
Research and development expense | 6,474,441 | 5,338,962 | € 3,390,677 |
Other current assets | 64,664 | 219,400 | 21,987 |
Other prepaid expense | 378,148 | 103,540 | € 18,247 |
Director [Member] | |||
Related Party Transaction [Line Items] | |||
Other prepaid expense | 200,000 | ||
Allowance For Corporate Equity [Member] | |||
Related Party Transaction [Line Items] | |||
Other current assets | 180,000 | ||
Accruing Financial Interest Income On Time Deposit [Member] | |||
Related Party Transaction [Line Items] | |||
Other current assets | 38,000 | ||
Research And Development Expense Related Party [Member] | |||
Related Party Transaction [Line Items] | |||
Research and development expense | € 430,000 | € 698,000 |
Schedule of fixed assets,net (D
Schedule of fixed assets,net (Details) - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Abstract] | |||
Software (ERP Implementation) | € 87,800 | € 87,800 | |
Computer | 35,971 | 31,307 | 24,869 |
Furniture and fixtures | 13,005 | 4,676 | 5,010 |
Total fixed assets | 136,776 | 123,783 | 29,879 |
Less: accumulated depreciation | (53,799) | (12,144) | (6,789) |
Fixed assets, net | € 82,977 | € 111,639 | € 23,090 |
Fixed assets, net (Details Narr
Fixed assets, net (Details Narrative) - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | |||
Net of accumulated depreciation | € 87,800 | € 87,800 | |
Software and Software Development Costs [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Net of accumulated depreciation | € 53,144 | € 87,800 |
Non-current assets right of u_2
Non-current assets right of use (ROU) (Details Narrative) | 12 Months Ended |
Dec. 31, 2023 EUR (€) | |
Non-current Assets Right Of Use | |
Annual lease payment | € 13,967 |
Monthly lease payment | € 1,164 |
Lease, description | lease payment will remain fixed for the four (4) years |
Operating lease discount rate | 6.25% |
Operating lease liability | € 49,320 |
Net present value of right of use asset and liability | 27,200 |
Lease liability current | 12,600 |
Long term liability | € 14,600 |
Schedule of other non-current a
Schedule of other non-current assets (Details) - Nonrelated Party [Member] - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Defined Benefit Plan Disclosure [Line Items] | |||
Value Added Tax (VAT) | € 630,342 | € 912,424 | € 641,215 |
Research and development tax credit | 167,000 | 650,000 | 600,000 |
Other non-current assets | 207,218 | 39,079 | |
Total other non-current assets | € 1,004,560 | € 1,601,503 | € 1,241,215 |
Other non-current assets (Detai
Other non-current assets (Details Narrative) - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 |
Research and development percentage | 10% | 20% |
Other Current Assets [Member] | ||
Allowance for corporate equity | € 200,000 | |
Other Noncurrent Assets [Member] | Related Party [Member] | ||
Security deposit | € 3,350 |
Retirement benefit obligation (
Retirement benefit obligation (Details Narrative) - EUR (€) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Description of annual contributions | The annual accrual is approximately 7% of total pay, with no ceiling, and is revalued each year by applying a pre-established rate of return of 1.50%, plus 75% of the Consumer Price Index | |
Percentage of total pay | 7% | |
Obligation amount | € 164,655 | € 88,963 |
Schedule of equity method inves
Schedule of equity method investment and ownership percentage (Details) | Jan. 01, 2021 EUR (€) |
Total | € 37,056 |
Quota A [Member] | |
Total | € 10,458 |
Equity method investment, ownership percentage | 28% |
Quota B [Member] | |
Total | € 6,886 |
Equity method investment, ownership percentage | 19% |
Quota C [Member] | |
Total | € 8,645 |
Equity method investment, ownership percentage | 23% |
Quota D [Member] | |
Total | € 4,034 |
Equity method investment, ownership percentage | 11% |
Quota E [Member] | |
Total | € 7,033 |
Equity method investment, ownership percentage | 19% |
Quota Total [Member] | |
Equity method investment, ownership percentage | 100% |
Quotaholders_ and shareholder_3
Quotaholders’ and shareholders’ equity (Details Narrative) - EUR (€) | 1 Months Ended | 12 Months Ended | |||||||||
Dec. 27, 2021 | Dec. 15, 2021 | May 20, 2021 | Apr. 01, 2021 | Jan. 01, 2021 | Jul. 31, 2023 | Apr. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Corporate capital, percentage | 100% | ||||||||||
Proceeds from divestiture of businesses | € 50,000,000 | ||||||||||
Exercise of Quota B options | € 715 | € 715 | |||||||||
Number of shares repurchased | 172 | ||||||||||
Net equity increase | € 543 | ||||||||||
Per share | € 300 | ||||||||||
Minimum capital amount | € 50,000 | ||||||||||
Additional Paid in Capital | € 37,139,431 | ||||||||||
Number of shares converted | 15,000,000 | ||||||||||
Shares isssued in IPO | 100 | ||||||||||
Number of ordinary shares subscribed | 720,114 | ||||||||||
Additional American Depository Shares | 2,400,000 | ||||||||||
Number of shares outstanding | 18,216,958 | 18,216,858 | 18,216,858 | ||||||||
Net listing costs | € 3,900,000 | ||||||||||
IPO [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Shares isssued in IPO | 3,120,114 | ||||||||||
Net listing costs | € 29,000,000 | ||||||||||
Over-Allotment Option [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Additional American Depository Shares | 96,744 | ||||||||||
Quota A [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock, voting rights | Quota A had voting rights. | ||||||||||
Quota B [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock, voting rights | Quota B had no voting rights | ||||||||||
Nominal amount | € 1 | ||||||||||
Exercise of Quota B options | € 715 | € 715 | |||||||||
Number of shares repurchased | 172 | ||||||||||
Net equity increase | € 543 | ||||||||||
Per share | € 1 | ||||||||||
Corporate Capital amount | € 37,771 | € 37,056 |
Schedule of Outstanding Stock O
Schedule of Outstanding Stock Options (Details) - EUR (€) | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Payment Arrangement [Abstract] | ||||
Number of options outstanding, Beginning | 540,523 | 546 | ||
Weighted average exercise price outstanding, Beginning | € 4.99 | € 1 | ||
Weighted average remaining contractual term outstanding | 6 years 6 months 10 days | 7 years 3 months 18 days | 1 year | |
Aggregate intrinsic value outstanding, Beginning | € 272,480 | € 584,132 | ||
Number of options, Granted | 46,400 | 540,523 | 169 | |
Weighted average exercise price, Granted | € 5.30 | € 4.99 | € 1 | |
Weighted average remaining contractual term, Granted | 9 years 2 months 1 day | 7 years 3 months 18 days | ||
Aggregate intrinsic value , Granted | € 272,480 | € 183,831 | ||
Number of options, Vested and exercised | 715 | |||
Weighted average exercise price, Vested and exercised | € 1 | |||
Aggregate intrinsic value, Vested and exercised | € 777,920 | |||
Number of options, Cancelled or forfeited | ||||
Weighted average exercise price, Cancelled or forfeited | ||||
Aggregate intrinsic value, Cancelled or forfeited | ||||
Number of options outstanding, Ending | 586,923 | 540,523 | 546 | |
Weighted average exercise price outstanding, Ending | € 4.84 | € 4.99 | € 1 | |
Aggregate intrinsic value outstanding,Ending | € 67,596 | € 272,480 | € 584,132 | |
Number of options,Exercisable | 382,785 | 237,129 | ||
Weighted average exercise price, Exercisable | € 5.11 | € 5.66 | ||
Weighted average remaining contractual term, Exercisable | 5 years 5 months 8 days | 4 years 5 months 1 day | ||
Aggregate intrinsic value, Exercisable | € 33,796 | € 61,988 | ||
Number of options outstanding, Expected to vest | 204,138 | 303,394 | ||
Weighted average exercise price outstanding, Expected to vest | € 4.34 | € 4.67 | ||
Weighted average remaining contractual term (years) Outstanding expected to vest | 8 years 6 months 29 days | 9 years 6 months 18 days | ||
Aggregate intrinsic value outstanding, Expected to vest | € 33,800 | € 210,492 |
Schedule of share based compens
Schedule of share based compensation expenses (Details) - EUR (€) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total | € 739,884 | € 722,735 | € 497,104 |
Unrecognized expense | 907,683 | 1,639,082 | 0 |
Research and Development Expense [Member] | Nonrelated Party [Member] | |||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total | 73,392 | 35,164 | 82,669 |
Research and Development Expense [Member] | Related Party [Member] | |||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total | 179,480 | ||
General and Administrative Expense [Member] | Nonrelated Party [Member] | |||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total | 505,828 | 486,962 | 234,955 |
General and Administrative Expense [Member] | Related Party [Member] | |||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total | € 160,664 | € 200,609 |
Share-based compensation (Detai
Share-based compensation (Details Narrative) | 1 Months Ended | 12 Months Ended | |||||||||
Mar. 31, 2023 $ / shares shares | Jul. 31, 2022 EUR (€) € / shares | Jul. 30, 2022 shares | Apr. 30, 2022 EUR (€) € / shares shares | May 31, 2021 shares | Apr. 30, 2021 EUR (€) | Dec. 31, 2023 EUR (€) € / shares shares | Dec. 31, 2022 EUR (€) € / shares shares | Dec. 31, 2021 EUR (€) € / shares shares | Mar. 31, 2023 EUR (€) | Dec. 31, 2020 shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Shares repurchased | € | € 172 | ||||||||||
New option grants | € | € 169 | ||||||||||
Vesting of options | € | 546 | € 33,800 | € 210,492 | ||||||||
Shares issued and exercised | € | 715 | € 715 | |||||||||
Number of ordinary shares | shares | 2,700,000 | ||||||||||
Percentage of total outstanding common shares | 10% | ||||||||||
Granted stock options | shares | 540,523 | ||||||||||
Exercise price per share | € / shares | € 4.76 | € 6.38 | |||||||||
Number of options available for grant | shares | 1,234,772 | 1,281,162 | |||||||||
Number of stock options awarded | shares | 46,400 | 540,523 | 169 | ||||||||
Outstanding stock options | shares | 586,923 | 540,523 | 546 | ||||||||
Unrecognized expense | € | € 907,683 | € 1,639,082 | € 0 | ||||||||
Fair value of options granted | € | € 739,884 | € 722,735 | 497,104 | ||||||||
Weighted average fair value | € | € 1,088 | ||||||||||
Weighted average fair value of options granted | € / shares | € 4.84 | € 4.99 | |||||||||
Weighted average shares | shares | 18,216,907 | 18,216,858 | 15,083,825 | ||||||||
Common stock par value | € / shares | € 0 | € 0 | |||||||||
Board of Directors Chairman [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Granted stock options | shares | 147,783 | ||||||||||
Unrecognized expense | € | € 240,043 | ||||||||||
Director And Officers And Employee [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Granted stock options | shares | 392,740 | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Terms of Award | The director NSOs vested monthly over a one-year period with a 10-year term. The officer and employee NSOs vested monthly over a four (4) year period with a 10-year term; however, the vesting of the officer NSOs were adjusted based on hire date per their employment contracts | ||||||||||
Director [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Exercise price per share | $ / shares | $ 5.62 | ||||||||||
Number of stock options awarded | shares | 46,400 | ||||||||||
Director And Employee [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Unrecognized expense | € | € 482,692 | € 199,890 | |||||||||
Share-Based Payment Arrangement, Option [Member] | |||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||
Shares repurchased | € | € 172 | ||||||||||
Outstanding stock options | shares | 382,785 |
Schedule of third party and rel
Schedule of third party and related party expenses (Details) - EUR (€) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |||
Total | € 6,474,441 | € 5,338,962 | € 3,390,677 |
Consultants and Other Third Parties [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 1,636,455 | 1,530,423 | 1,657,620 |
Materials And Supplies [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 3,639,920 | 2,790,982 | 1,231,019 |
Compensation [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 1,113,489 | 992,281 | 499,849 |
Travel And Entertainment [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 44,243 | 596 | |
Other [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 40,334 | 25,276 | 1,593 |
Third Parties [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 4,496,974 | 4,032,684 | 2,463,725 |
Third Parties [Member] | Consultants and Other Third Parties [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 305,289 | 804,341 | 946,156 |
Third Parties [Member] | Materials And Supplies [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 3,639,920 | 2,790,982 | 1,231,019 |
Third Parties [Member] | Compensation [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 467,557 | 412,085 | 284,957 |
Third Parties [Member] | Travel And Entertainment [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 44,243 | ||
Third Parties [Member] | Other [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 39,965 | 25,276 | 1,593 |
Related Parties [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 1,977,467 | 1,306,278 | 926,952 |
Related Parties [Member] | Consultants and Other Third Parties [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 1,331,166 | 726,082 | 711,464 |
Related Parties [Member] | Materials And Supplies [Member] | |||
Related Party Transaction [Line Items] | |||
Total | |||
Related Parties [Member] | Compensation [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 645,932 | 580,196 | 214,892 |
Related Parties [Member] | Travel And Entertainment [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 596 | ||
Related Parties [Member] | Other [Member] | |||
Related Party Transaction [Line Items] | |||
Total | € 369 |
Schedule of third party and gen
Schedule of third party and general and administrative expenses (Details) - EUR (€) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |||
Total | € 5,258,501 | € 5,705,030 | € 2,296,596 |
Compensation [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 2,535,367 | 2,562,854 | 920,801 |
Accounting Legal and Other Professional [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 1,026,534 | 781,817 | 390,134 |
Communication and IT Related [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 166,416 | 171,380 | 52,230 |
Facility and Insurance Related [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 21,911 | 1,256,507 | 85,580 |
Consultants and Other Third Parties [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 610,103 | 593,788 | 675,688 |
Other [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 898,170 | 338,684 | 172,163 |
Third Parties [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 3,923,550 | 4,414,381 | 1,706,878 |
Third Parties [Member] | Compensation [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 1,218,299 | 1,293,880 | 353,177 |
Third Parties [Member] | Accounting Legal and Other Professional [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 1,026,534 | 781,817 | 390,134 |
Third Parties [Member] | Communication and IT Related [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 166,416 | 171,380 | 52,230 |
Third Parties [Member] | Facility and Insurance Related [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 6,180 | 1,241,692 | 71,181 |
Third Parties [Member] | Consultants and Other Third Parties [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 610,103 | 593,788 | 675,688 |
Third Parties [Member] | Other [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 896,018 | 331,824 | 164,468 |
Related Parties [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 1,334,951 | 1,290,649 | 589,718 |
Related Parties [Member] | Compensation [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 1,317,068 | 1,268,974 | 567,624 |
Related Parties [Member] | Accounting Legal and Other Professional [Member] | |||
Related Party Transaction [Line Items] | |||
Total | |||
Related Parties [Member] | Communication and IT Related [Member] | |||
Related Party Transaction [Line Items] | |||
Total | |||
Related Parties [Member] | Facility and Insurance Related [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 15,731 | 14,815 | 14,399 |
Related Parties [Member] | Consultants and Other Third Parties [Member] | |||
Related Party Transaction [Line Items] | |||
Total | |||
Related Parties [Member] | Other [Member] | |||
Related Party Transaction [Line Items] | |||
Total | € 2,152 | € 6,860 | € 7,695 |
Schedule of accounts payable to
Schedule of accounts payable to related parties (Details) - Related Party [Member] - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Related Party Transaction [Line Items] | |||
Total | € 170,888 | € 151,988 | € 25,047 |
San Raffaele Hospital O S R [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 170,888 | 150,206 | 25,047 |
Pierluigi Paracchi [Member] | |||
Related Party Transaction [Line Items] | |||
Total | |||
Carlo Russo [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 198 | ||
Richard Slansky [Member] | |||
Related Party Transaction [Line Items] | |||
Total | € 1,584 |
Schedule of accrued expenses to
Schedule of accrued expenses to related parties (Details) - EUR (€) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Related Party Transaction [Line Items] | |||
Total | € 861,578 | € 489,207 | € 132,141 |
San Raffaele Hospital O S R [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 413,935 | 176,559 | 19,201 |
Pierluigi Paracchi [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 175,254 | 112,501 | 25,000 |
Richard Slansky [Member] | |||
Related Party Transaction [Line Items] | |||
Total | 116,738 | 81,369 | 53,502 |
Carlo Russo [Member] | |||
Related Party Transaction [Line Items] | |||
Total | € 155,651 | € 118,778 | € 34,438 |
Related parties (Details Narrat
Related parties (Details Narrative) | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||
Apr. 20, 2023 EUR (€) | Nov. 01, 2021 USD ($) | Jul. 31, 2022 EUR (€) | Feb. 28, 2022 EUR (€) | Dec. 31, 2022 EUR (€) | Dec. 31, 2023 USD ($) | Dec. 31, 2023 EUR (€) | Dec. 31, 2022 EUR (€) | Dec. 31, 2021 EUR (€) | Apr. 30, 2022 EUR (€) | Jun. 30, 2021 EUR (€) | |
Related Party Transaction [Line Items] | |||||||||||
Research and development expense | € 6,474,441 | € 5,338,962 | € 3,390,677 | ||||||||
Tax | € 700,000 | 400,000 | 700,000 | 1,200,000 | |||||||
Amended and Restated OSR License Agreement [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Upfront fee | € 250,000 | ||||||||||
Commitments, description | We are also obligated to carry out our development activities using qualified and experienced professionals and sufficient level of resources. In particular, consistent with the terms of the Original OSR License Agreement, the ARLA continues to require us to invest (a) at least €5,425,000 with respect to the development of the licensed products, and (b) at least €2,420,000 with respect to the manufacturing of such licensed products (subject to certain adjustments) | We are also obligated to carry out our development activities using qualified and experienced professionals and sufficient level of resources. In particular, consistent with the terms of the Original OSR License Agreement, the ARLA continues to require us to invest (a) at least €5,425,000 with respect to the development of the licensed products, and (b) at least €2,420,000 with respect to the manufacturing of such licensed products (subject to certain adjustments) | |||||||||
Sublicense Agreement [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
License fees | € 875,000 | ||||||||||
Amendment to OSR Amendedand Restated License Agreement [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Agreement fee | € 400,000 | ||||||||||
Total project amounting | 197,500 | ||||||||||
Amendment to OSR Amendedand Restated License Agreement [Member] | First Solid Cancer Indication Option Fee [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Cumulative expense | 10,800,000 | ||||||||||
Amendment to OSR Amendedand Restated License Agreement [Member] | Second Solid Cancer Indication Option Fee [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Option fee | 1,000,000 | ||||||||||
First Indication [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Future option fees | 1,000,000 | ||||||||||
Second Indication [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Future option fees | 500,000 | ||||||||||
Third Indication [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Future option fees | 300,000 | ||||||||||
Related Party [Member] | OSR Sponsor Research Agreement [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Payment for research agreement | 250,000 | ||||||||||
Pierluigi Paracchi [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Gross salary | € 420,000 | ||||||||||
Percentage of annual bonus | 40% | ||||||||||
Pierluigi Paracchi [Member] | Minimum [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Percentage of annual bonus | 20% | ||||||||||
Pierluigi Paracchi [Member] | Maximum [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Percentage of annual bonus | 40% | ||||||||||
Director [Member] | Pierluigi Paracchi [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Accrued bonus | 37,000 | 37,000 | € 60,000 | € 23,000 | |||||||
Employee benefits and share based compensation | 692,000 | 624,000 | |||||||||
Gross bonus | 112,501 | 168,000 | 112,501 | ||||||||
Naldini [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Employee benefits and share based compensation | 100,000 | ||||||||||
Annual fee | 100,000 | ||||||||||
Dr.Gentner [[Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Annual fee | 45,000 | ||||||||||
Gentner [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Employee benefits and share based compensation | € 45,000 | ||||||||||
XDG Biomed LLC [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Percentage of annual bonus | 30% | 30% | |||||||||
Recurring fees | € 300,000 | ||||||||||
Performance Bonus | 50,000 | ||||||||||
Gross salary | $ | $ 500,000 | ||||||||||
Mr.Russo [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Accrued bonus | 112,000 | 156,000 | 112,000 | ||||||||
Mr.Russo [Member] | Related Party [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Interest expense | 592,000 | 580,000 | |||||||||
Richard Slansky [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Percentage of annual bonus | 30% | ||||||||||
Accrued bonus | € 77,000 | 116,000 | 77,000 | ||||||||
Comprehensive loss | € 201,000 | ||||||||||
Richard Slansky [Member] | Minimum [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Gross annual compensation | $ | $ 300,000 | ||||||||||
Richard Slansky [Member] | Maximum [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Gross annual compensation | $ | $ 375,000 | ||||||||||
Richard Slansky [Member] | Related Party [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Interest expense | 456,000 | 445,000 | |||||||||
San Raffle Hospital [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Research and development expense | 6,500,000 | 5,300,000 | 3,400,000 | ||||||||
Research and development expense gross | € 6,900,000 | € 6,000,000 | € 4,600,000 |
Schedule of company obligations
Schedule of company obligations by contractual maturity (Details) | Dec. 31, 2023 EUR (€) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Total | € 514,299 |
Less than a year | 398,252 |
4 to 5 years | |
More than 5 years | |
1 to 3 years | 116,047 |
OSR [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Total | 14,952 |
OSR Operating Leases And Office Rent [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Less than a year | 14,952 |
4 to 5 years | |
More than 5 years | |
OSR - SRA & ARLA [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Total | 250,000 |
Less than a year | 166,600 |
1 to 3 years | 83,400 |
AGC Manufacturing [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Total | 234,754 |
Less than a year | 209,704 |
4 to 5 years | |
More than 5 years | |
1 to 3 years | 25,050 |
Insurance Policy [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Total | 14,593 |
Less than a year | 6,996 |
4 to 5 years | |
More than 5 years | |
1 to 3 years | € 7,597 |
Commitments and contingencies_2
Commitments and contingencies (Details Narrative) - EUR (€) | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||
Feb. 28, 2023 | Nov. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Loss Contingencies [Line Items] | |||||
Investment Owned, Balance, Principal Amount | € 5,425,000 | ||||
Payment for rent | 15,000 | ||||
Lease cost | € 15,000 | ||||
Minimum [Member] | |||||
Loss Contingencies [Line Items] | |||||
Royalty fees percentage | 0.50% | ||||
Maximum [Member] | |||||
Loss Contingencies [Line Items] | |||||
Royalty fees percentage | 1% | ||||
OSR [Member] | |||||
Loss Contingencies [Line Items] | |||||
Percentage of royalties | 4% | ||||
San Raffaele Hospital [Member] | |||||
Loss Contingencies [Line Items] | |||||
Incurred expenses | € 2,500,000 | € 1,300,000 | |||
Manufacturing costs | € 9,100,000 | ||||
Original OSR License Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Commitments, description | In particular, consistent with the terms of the Original OSR License Agreement, the ARLA continues to require us to invest (a) at least €5,425,000 with respect to the development of the licensed products, and (b) at least €2,420,000 with respect to the manufacturing of such licensed products (subject to certain adjustments). | ||||
AGC Biologics Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Potential milestone | € 300,000 | ||||
Technology transfer fee | 500,000 | ||||
AGC Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Manufacturing costs | 1,000,000 | ||||
LVV Batch [Member] | |||||
Loss Contingencies [Line Items] | |||||
Manufacturing costs | € 311,280 | € 311,280 | |||
Process Transfer Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Raw materials | 405,000 | ||||
Raw materials handling | 40,500 | ||||
Raw material costs | € 24,000 | ||||
SOW [Member] | |||||
Loss Contingencies [Line Items] | |||||
Raw material costs | € 1,500,000 | 600,000 | |||
Raw material and third party costs | € 700,000 | ||||
Master Service Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Production cost | € 200,000 |