Exhibit 99.1
Genenta Science S.p.A.
Consolidated Statements of Operations and Comprehensive Loss
| 2024 | 2023 | |||||||
| Six Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| Operating expenses | ||||||||
| Research and development | € | 2,040,390 | € | 3,921,802 | ||||
| General and administrative | 2,477,978 | 2,878,373 | ||||||
| Total operating expenses | 4,518,368 | 6,800,175 | ||||||
| Loss from operations | (4,518,368 | ) | (6,800,175 | ) | ||||
| Other income (expense) | ||||||||
| Other income | 180,781 | 114,992 | ||||||
| Finance income | 145,290 | 77,999 | ||||||
| Net exchange rate gain (loss) | 153,791 | (152,041 | ) | |||||
| Total other income, net | 479,862 | 40,950 | ||||||
| Loss before income taxes | (4,038,506 | ) | (6,759,225 | ) | ||||
| Income tax benefit (expense) | - | - | ||||||
| Net loss | (4,038,506 | ) | (6,759,225 | ) | ||||
| Net loss per share - basic | € | (0.22 | ) | € | (0.37 | ) | ||
| Weighted average number of shares outstanding - basic and diluted | ||||||||
| Other comprehensive income (loss) | ||||||||
| Total change of marketable debt securities | (64,288 | ) | - | |||||
| Change in foreign currency translation | (16,081 | ) | - | |||||
| Total other comprehensive income | (80,369 | ) | - | |||||
| Comprehensive loss | € | (4,118,875 | ) | € | (6,759,225 | ) | ||
The accompanying notes are an integral part of these consolidated financial statements.
Genenta Science S.p.A.
Consolidated Balance Sheets
| At June 30, | At December 31, | |||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | € | 6,187,966 | € | 3,691,420 | ||||
| Marketable securities | 10,718,210 | 15,084,284 | ||||||
| Prepaid expenses and other current assets | 1,663,297 | 2,480,554 | ||||||
| Total current assets | 18,569,473 | 21,256,258 | ||||||
| Non-current assets | ||||||||
| Fixed assets, net | € | 62,714 | € | 82,977 | ||||
| Other non-current assets | 381,670 | 1,004,560 | ||||||
| Other non-current assets - related party | 3,350 | 3,350 | ||||||
| Other non-current assets | 3,350 | 3,350 | ||||||
| Total non-current assets | 447,734 | 1,090,887 | ||||||
| Total assets | € | 19,017,207 | € | 22,347,145 | ||||
| Liabilities and shareholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | € | 405,846 | € | 294,975 | ||||
| Accounts payable - related party | 189,762 | 170,888 | ||||||
| Accounts payable | 189,762 | 170,888 | ||||||
| Accrued expenses | 260,051 | 153,136 | ||||||
| Accrued expenses - related party | 698,868 | 861,578 | ||||||
| Accrued expenses | 698,868 | 861,578 | ||||||
| Other current liabilities | 441,296 | 255,062 | ||||||
| Total current liabilities | 1,995,823 | 1,735,639 | ||||||
| Non-current liabilities | ||||||||
| Other non current liabilities | 7,981 | 14,594 | ||||||
| Retirement benefit obligation | 196,368 | 164,655 | ||||||
| Total long-term liabilities | 204,349 | 179,249 | ||||||
| Commitments and contingencies | - | - | ||||||
| Shareholders’ equity | ||||||||
| Ordinary shares, par value, shares authorized and and shares issued and outstanding, respectively | 67,847,793 | 67,344,140 | ||||||
| Accumulated deficit | (51,181,531 | ) | (47,143,025 | ) | ||||
| Accumulated other comprehensive income | 150,773 | 231,142 | ||||||
| Total shareholders’ equity | 16,817,035 | 20,432,257 | ||||||
| Total liabilities and shareholders’ equity | € | 19,017,207 | € | 22,347,145 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
Genenta Science S.p.A.
Consolidated Statements of Changes in Shareholders’ Equity
| Common shares outstanding | Common stock, no par value | Accumulated deficit | Accumulated other comprehensive income | Total | ||||||||||||||||
| Balance at December 31, 2022 | € | 18,216,858 | € | 66,603,725 | € | (35,465,559 | ) | € | - | € | 31,138,166 | |||||||||
| Share-based compensation | - | 415,433 | - | - | 415,433 | |||||||||||||||
| Cumulative translation adjustment | - | - | 9,716 | - | 9,716 | |||||||||||||||
| Net loss | - | - | (6,759,225 | ) | - | (6,759,225 | ) | |||||||||||||
| Balance at June 30, 2023 (Unaudited) | € | 18,216,858 | € | 67,019,158 | € | (42,215,068 | ) | € | - | € | 24,804,090 | |||||||||
| Share-based compensation | - | 324,451 | - | - | 324,451 | |||||||||||||||
| Capital increase ATM program | 100 | 531 | - | - | 531 | |||||||||||||||
| Cumulative translation adjustment | - | - | (9,716 | ) | - | (9,716 | ) | |||||||||||||
| Other comprehensive income | - | - | (32,011 | ) | 231,142 | 199,131 | ||||||||||||||
| Net loss | - | - | (4,886,230 | ) | - | (4,886,230 | ) | |||||||||||||
| Balance at December 31, 2023 | € | 18,216,958 | € | 67,344,140 | € | (47,143,025 | ) | € | 231,142 | € | 20,432,257 | |||||||||
| Balance | € | 18,216,958 | € | 67,344,140 | € | (47,143,025 | ) | € | 231,142 | € | 20,432,257 | |||||||||
| Share-based compensation | - | 232,768 | - | - | 232,768 | |||||||||||||||
| Capital increase ATM program | 72,908 | 270,885 | - | - | 270,885 | |||||||||||||||
| Other comprehensive income | - | - | - | (80,369 | ) | (80,369 | ) | |||||||||||||
| Net loss | - | - | (4,038,506 | ) | - | (4,038,506 | ) | |||||||||||||
| Balance at June 30, 2024 (Unaudited) | € | 18,289,866 | € | 67,847,793 | € | (51,181,531 | ) | € | 150,773 | € | 16,817,035 | |||||||||
| Balance | € | 18,289,866 | € | 67,847,793 | € | (51,181,531 | ) | € | 150,773 | € | 16,817,035 | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
Genenta Science S.p.A.
Consolidated Statements of Cash Flows
| 2024 | 2023 | |||||||
| Six Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| (in Euros) | ||||||||
| Cash flows from operating activities | ||||||||
| Net loss | € | (4,038,506 | ) | € | (6,759,225 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Foreign exchange adjustment | - | 9,716 | ||||||
| Depreciation expense | 22,132 | 21,143 | ||||||
| Retirement benefit obligation | 31,713 | 40,486 | ||||||
| Share-based compensation | 232,768 | 415,433 | ||||||
| Net gain (loss) on purchase of marketable securities | - | (9,517 | ) | |||||
| Changes in operating assets and liabilities | ||||||||
| Prepaid expenses and other current assets | 817,258 | (377,721 | ) | |||||
| Other non-current assets | 622,890 | (502,229 | ) | |||||
| Accounts payable | 110,871 | (692,780 | ) | |||||
| Accounts payable - related party | 18,874 | (21,768 | ) | |||||
| Accrued expenses | 106,915 | 245,976 | ||||||
| Accrued expenses - related party | (162,710 | ) | 143,174 | |||||
| Other current liabilities | 186,234 | (86,603 | ) | |||||
| Other non-current liabilities | (6,613 | ) | (6,214 | ) | ||||
| Net cash used in operating activities | (2,058,174 | ) | (7,580,129 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of marketable securities | (8,998,556 | ) | (9,989,030 | ) | ||||
| Proceeds from maturities of marketable securities | 13,300,341 | - | ||||||
| Purchases of fixed assets | (1,869 | ) | (12,437 | ) | ||||
| Net cash (used in) provided by investing activities | 4,299,916 | (10,001,467 | ) | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from ATM program | 270,885 | - | ||||||
| Net cash provided by financing activities | 270,885 | - | ||||||
| Effect of exchange rate changes | (16,081 | ) | - | |||||
| Net increase (decrease) in cash and cash equivalents | 2,496,546 | (17,581,596 | ) | |||||
| Cash and cash equivalents at beginning of period | 3,691,420 | 29,794,856 | ||||||
| Cash and cash equivalents at end of period | € | 6,187,966 | € | 12,213,260 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
Genenta Science S.p.A.
Notes to the Consolidated Financial Statements
1. Nature of business and history
Genenta Science S.p.A. (the “Company” or “Genenta”) – formerly Genenta Science S.r.l., a “società a responsabilità limitata” (“S.r.l.”), which is similar to a limited liability company in the United States (“U.S.”) converted to a “società per azioni” (“S.p.A.”), an Italian corporation 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 million ordinary shares at no par value. (See Note 10. Shareholders’ equity.) The registered office (or headquarters) is located in Milan, Italy. The Company’s reporting currency is Euros (“EUR” or “€”). In May 2021, the Company formed a wholly owned, Delaware incorporated subsidiary, Genenta Science, Inc. (“U.S. Subsidiary”), intended to support U.S. employees and future operations in the U.S.. The U.S. Subsidiary operates in U.S. Dollars (“USD” or “$”).
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 (“Nasdaq”) on December 15, 2021. Through the IPO, new ordinary shares with no par value were issued. ordinary shares were subscribed by the Company’s existing shareholders through a reserved offering, while American Depository Shares (“ADSs”), each representing one of the Company’s ordinary shares, were offered to the public and listed on Nasdaq. Subsequently, on December 27, 2021, the Company’s underwriter exercised a portion of its “green shoe” allotment for an additional ADSs. The total number of shares outstanding resulting at December 31, 2021 was . Through the IPO, approximately €29 million was raised, net of listing costs (approximately €3.9 million).
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 million, subject currently to the limits set forth in Instruction I.B.6(a) of Form S-3 (referred to as “baby shelf” rules).
In June 2023, the Company’s shareholders reduced the number of directors from seven (7) to five (5).
In July 2023, the Company issued ADSs for net proceeds of approximately € (or $), increasing the total number of shares outstanding to , pursuant to a Controlled Equity OfferingSM Sales Agreement, dated May 12, 2023 (the “Prior Sales Agreement”), between the Company and Cantor Fitzgerald & Co. (“Cantor”), as agent, subject to the terms and conditions described in the Prior Sales Agreement and SEC rules and regulations (the “Prior ATM Offering”).
In March 2024, the Company issued ADSs for net proceeds of approximately €(or $), bringing the total number of ordinary shares outstanding to , pursuant to the Prior Sales Agreement. On March 28, 2024, the Company and Cantor mutually agreed to terminate the Prior Sales Agreement.
On April 26, 2024, the Company entered into an ATM Sales Agreement (the “Current Sales Agreement”) with Capital One Securities, Inc. and Virtu Americas LLC (the “Sales Agents”), pursuant to which the Company may offer and sell ADSs, for an aggregate offering price of up to $16,362,816 from time to time through or to the Sales Agents, acting as sales agents or principals, subject to the terms and conditions described in the Current Sales Agreement and SEC rules and regulations (the “Current ATM Offering”).
In May 2024, the Company’s shareholders approved an amendment of article 9 of the Company’s Bylaws, introducing increased voting rights by introducing a mechanism whereby each ordinary share owned by the same subject (either an entity or an individual) for a continuous period of not less than twenty-four months entitles the holder to a double vote and therefore to an increase from one to two votes per share. In addition, a further vote is attributed at the end of each twelve-month period, following the first vesting period of twenty-four months, in which the ordinary share has belonged to the same entity or individual, up to a total maximum of 10 votes per ordinary share. The amendment applies to only ordinary shares, not ADSs.
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 (the “Board”) selected Renal Cell Cancer (“RCC”) as the second solid tumor indication for Temferon. The Company is currently finalizing 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 €4.0 million and €6.8 million for the six months ended June 30, 2024, and June 30, 2023, respectively. In addition, at June 30, 2024, the Company had an accumulated deficit of €51.2 million. The Company has primarily funded these losses through the proceeds from sales of convertible debt and equity quotas, before the Company’s conversion into an S.p.A., and then through the proceeds from its IPO. The Company has incurred recurring losses and expects to continue to incur losses for the foreseeable future. In addition, the Company expects that its existing cash and cash equivalents on hand of €6.2 million, together with the other short-term marketable securities of €10.7 million as of June 30, 2024 will be sufficient to fund current planned operations and capital expenditure requirements for at least the next twelve months. However, the future viability of the Company is dependent on its ability to raise additional capital to finance its operations. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to continue as a going concern, as well the ability to pursue its business strategies. There can be no assurance that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all.
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, debt or convertible securities through public offerings or private placements, including sales of ADSs pursuant to the Current 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 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 war between Russia and Ukraine, the ongoing conflict in the Middle East or other macroeconomic conditions. 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, its ability to continue as a going concern, 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 Italian and U.S. government treasury bills and notes with short-term maturities. 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 section.
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 June 30, 2024, the Company maintained €6.2 million in cash and cash equivalents and €10.7 million in marketable securities. Changes in the USD/EUR exchange rate could increase/decrease the Company’s operating expenses, especially as more costs are incurred in the U.S. or, as USD are exchanged for EUR to cover European operating costs. As the Company continues to grow its business, the Company’s results of operations and cash flows might be subject to significant fluctuations due to changes in foreign currency exchange rates, which could adversely impact the Company’s results of operations.
Currently, the Company has recorded an unrealized net gain from exchange rate of approximately €0.2 million. The Company does not currently hedge its foreign currency exchange risk. In the future, the Company may enter into formal currency hedging transactions to decrease the risk of financial exposure from fluctuations in the exchange rates of its principal operating currencies. These measures, however, may not adequately protect the Company from the material adverse effects of such fluctuations.
2. Summary of significant accounting policies
Basis of presentation
The consolidated financial statements of the Company are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial reporting and in accordance with Regulation S-X, Rule 10-01 promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, the financial statements may not include all the information and footnotes required by U.S. GAAP for complete financial statements. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification, or ASC, and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
The accompanying unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 20-F filed with the SEC on March 29, 2024, as amended by Amendment No. 1 of Form 20-F/A filed with the SEC on April 1, 2024. The balance sheet as of December 31, 2023 was derived from audited consolidated financial statements included in the Company’s Annual Report but does not include all disclosures required by U.S. GAAP.
Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these interim financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of the Company’s management, necessary to fairly state the results of the interim period. The interim results are not necessarily indicative of results to be expected for the full year.
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 U.S. 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 and clinical expenses and related milestone payments, share-based compensation expense, valuation of research and development 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 like short-term marketable securities, 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 Statements of Cash Flows, 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 reported at fair value and are detailed as follows:
Schedule of cash and cash equivalents
| At June 30, | At December 31, | |||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| Cash in bank | € | 3,945,143 | € | 3,687,402 | ||||
| Cash in short-term marketable securities | 2,238,823 | - | ||||||
| Cash in hand & prepaid cards | 4,000 | 4,018 | ||||||
| Total cash and cash equivalents | € | 6,187,966 | € | 3,691,420 | ||||
Marketable securities
The Company’s marketable securities are maintained by management and investment managers and consist of highly rated domestic and 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 maturities 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 (“ASU 2016-13” or “ASC 326”), using the effective date method. As the Company had never recorded any other-than-temporary-impairment adjustments to its available-for-sale debt securities prior to the effective date, no transition provisions are applicable to the Company.
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 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 loss 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 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.
Net loss and comprehensive 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 six months ended June 30, 2024, the net loss was equal to €4.0 million and the comprehensive loss was equal to €4.1 million. At June 30, 2023, the comprehensive loss was equal to the net loss.
Net loss per share (“EPS”) is computed in accordance with U.S. GAAP. Basic EPS is computed by dividing net loss by the weighted average number of ordinary shares outstanding during the period. Diluted EPS reflects potential dilution and is computed by dividing net loss by the weighted average number of ordinary shares outstanding during the period increased by the number of additional ordinary shares that would have been outstanding if all potential ordinary shares had been issued and were dilutive.
The EPS calculation was applied at the Company conversion to an S.p.A. in June 2021. Prior to the conversion to an S.p.A., the Company’s equity ownership interests were represented by quotas, as opposed to shares, and accordingly, an EPS calculation was not possible. The Company’s shareholders have authorized million ordinary shares. In July 2023, in the Prior ATM Offering, new ADSs were issued. In March 2024, additional ADSs were issued in the Current ATM Offering. At June 30, 2024, the Company had ordinary shares issued and outstanding, with approximately million ordinary shares reserved for the Company’s Equity Incentive Plan 2021–2035.
At June 30, 2024 and June 30, 2023, the Company had options on and ordinary shares outstanding, respectively, and ordinary share equivalents in the form of underwriters’ ordinary share warrants. Dr. Squinto, the Company’s former Chairman of the Board, held options on shares that expired unexercised as of April 2024.
Diluted EPS was not relevant at June 30, 2024 and June 30, 2023, as the effect of ordinary share equivalents, in the form of underwriters’ ordinary share warrants, and options on and ordinary shares, respectively, would have been anti-dilutive. (See Note 10. Shareholders’ equity and Note 11. Share-based compensation.)
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 and Comprehensive Loss. 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 the Consolidated Statements of Changes in Shareholders’ Equity as a cumulative translation adjustment. At June 30, 2024 and June 30, 2023, the currency translation impact was not material.
During the six months ended June 30, 2024, the unrealized foreign exchange net gain was €0.2 million. During the six months ended June 30, 2023, the unrealized foreign exchange net loss was €0.2 million. The minimal change in the net foreign exchange rate effect was due to the fluctuation in the USD exchange rate with the Euro.
Emerging growth company status
The Company is an “emerging growth company,” as defined in the U.S. Jumpstart Our Business Startups Act (the “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 JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period afforded by the 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 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 U.S. 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 research and development (“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 | |||||||||||||
| June 30, 2024 | ||||||||||||||||
| Total | Level 1 | Level 2 | Level 3 | |||||||||||||
| Cash and cash equivalents | € | 6,187,966 | 6,187,966 | € | - | € | - | |||||||||
| Marketable securities | 10,718,210 | 10,718,210 | - | - | ||||||||||||
| Total cash and cash equivalents and marketable securities | € | 16,906,176 | € | 16,906,176 | € | - | € | - | ||||||||
| 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 cash and cash equivalents and marketable securities | € | 18,775,704 | € | 18,775,704 | € | - | € | - | ||||||||
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 R&D
In line with the legislation in force at December 31, 2023, and for the fiscal year 2024, companies in Italy that invest in eligible R&D 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.
Starting with the fiscal year 2023 (“FY 2023”), for eligible R&D activities, the tax credit is equal to 10% of the eligible costs incurred, with a maximum annual amount of €5.0 million. In addition, the law extended the measure up to the tax period ended December 31, 2031.
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 R&D projects; | |
| ● | Expenses for extra-euro research contracts concerning the direct execution of eligible R&D activities by the provider; | |
| ● | Expenses for consulting services and equivalent services related to eligible R&D activities; and, | |
| ● | Expenses for materials, supplies, and other similar products used in R&D projects. |
The Company accounts for this receivable in accordance with International Accounting Standards (IAS) 20, Accounting for Government Grants and Disclosure of Government Assistance. The receivable is recognized when there is reasonable assurance that: (1) the recipient will comply with the relevant conditions; and (2) the grant will be received. The Company has elected to present net of the related expenditure on the Consolidated Statements of Operations and Comprehensive Loss.
While these tax credits can be carried forward indefinitely, the Company recognized an amount that 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.
To reward the efforts of employees, officers, directors, and certain consultants, and to promote the Company’s growth and development, the Board may approve, upon occasion, various share-based awards. The Company’s stock option plan (the “Equity Incentive Plan 2021–2025” or the “Plan”), pursuant to which stock options are granted, was originally approved on May 20, 2021.
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, to allow all stock options granted during the term of the Plan could provide for an exercise period of starting from the date of grant. (See Note 11. Share-based compensation.)
Currently, the Company has authorized options on ordinary shares (i.e., % of the number of shares outstanding, which was ordinary shares outstanding at June 30, 2024); however, as provided by the Plan, the Company may increase the authorized shares under the Plan up to a maximum of ordinary shares without further shareholder approval. Therefore, as the Company raises additional capital, the Board has the authority to issue options on to ordinary shares, as the number of issued and outstanding ordinary shares grows, i.e., the Company does not have to obtain further authorization from shareholders to increase the number of ordinary shares available for equity grants until the outstanding ordinary shares exceed .
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 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
Upon the closing of the Company’s IPO, the Company issued warrants to the underwriters of the offering (“Warrants”). The Warrants are exercisable at a per share exercise price equal to 125% of the public offering price (i.e., $) per ADS sold in the IPO. The Warrants are exercisable at any time and from time to time, in whole or in part, during the four and one-half-year period commencing June 13, 2022. 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 ROU 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 ROU 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 ROU asset. For operating leases, lease expense is recognized on a straight-line basis over the lease term.
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 payable monthly in the amount of €1,164. The lease payment will remain fixed for the four (4) years. The automobile lease was identified and accounted for as a finance-type lease.
For the initial measurement, the calculation of the net present value of the ROU asset and liability was made by using the discounted rate of 6.25% and was determined to be approximately €49,320. Lessee initial direct costs were deemed not material. Other non-lease component costs for lease insurance were accounted for separately from the lease. At June 30, 2024, the net present value of the ROU asset and liability amounted to approximately €21,004. The liability was determined to be €13,023 as a current liability and €7,981 as a long-term liability.
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 by taking into consideration the use, purpose, and financial-technical duration of the assets, based on their estimated useful economic lives. Leasehold improvement depreciation is recorded based on the shorter of: (i) the life of the leasehold improvement; or, (ii) 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 based on its estimated useful economic life. Amortization of leasehold improvements is computed using the straight-line method based on 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 six months ended June 30, 2024, and June 30, 2023.
Deferred offering costs
Deferred offering costs, which primarily consist of direct, incremental legal and accounting fees relating to fundraising activities (e.g., an IPO or other fundraising activities), are capitalized within prepaid expenses and other current assets before the offering and netted or offset with the offering proceeds upon closing of the offering.
For the six months ended June 30, 2024, the Company incurred approximately €0.2 million of ATM offering costs that were fully expensed as general and administrative costs in the Consolidated Statement of Operations and Comprehensive Loss.
For the six months ended June 30, 2023, the Company incurred approximately €0.3 million of ATM offering costs that were fully expensed as general and administrative costs in the Consolidated Statement of Operations and Comprehensive Loss.
Recently issued accounting pronouncements
In November 2023, the FASB issued ASU 2023-07 which amends ASC 280 to improve the information that a public entity discloses about its reportable segments and to address investor requests for more information about reportable segment expenses by requiring incremental disclosures for segment reporting. The effective date for ASU 2023-07 is for fiscal years beginning after December 15, 2023 and interim periods with fiscal years beginning after December 15, 2024. The amendment requires companies to disclose more information about their reportable segments, including: (1) significant segment expenses, (2) ‘other’ segment items, (3) the title and position of the chief operating decision maker (“CODM”), (4) how the CODM uses the reported measure(s) of segment profit or loss and (5) annual disclosures about a reportable segment’s profit or loss and assets. The Company will be providing the enhanced reportable segment financial disclosures effective with its Annual Report on Form 20-F for the year ending December 31, 2024.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which modifies the rules on income tax disclosures to require disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions. The guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted. ASU 2023-09 should be applied on a prospective basis, but retrospective application is permitted. The Company is currently evaluating the potential impact of adopting this new guidance on our consolidated financial statements and related disclosures.
In March 2024, the FASB issued ASU 2024-01, Scope Application of Profits Interest and Similar Awards, which clarifies how an entity determines whether a profits interest or similar award (hereafter a “profits interest award”) is (1) within the scope of Accounting Standards Codification (ASC) 718, Compensation — Stock Compensation, or (2) not a share-based payment arrangement and therefore within the scope of other guidance. For public business entities, ASU 2024-01 is effective for annual periods beginning after December 15, 2024, and interim periods within those annual periods. For all other entities, the amendments are effective for annual periods beginning after December 15, 2025, and interim periods within those annual periods. The Company currently expects that this ASU will not have a material impact on its consolidated financial statements.
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 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 12. Accumulated Other Comprehensive Income below.
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.
5. Income taxes
The Company is subject to taxation in Italy, and the U.S., through the U.S. Subsidiary. Taxation in Italy includes the standard corporate income tax (“IRES”) and a regional business tax (“IRAP”). 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. Due to the tax loss position reported, no income taxes were accrued for the six months ending June 30, 2024, and June 30, 2023, in Italy or the U.S. At June 30, 2024, the U.S, subsidiary 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 regard 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 Company, the prior five years of tax returns (2019-2023) are potentially subject to audit. For the U.S. Subsidiary, the open years for tax examination are 2021, 2022, and 2023.
At June 30, 2024, and June 30, 2023, the Company believes there were no significant differences with regard 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 DL 98/2011, at the end of 2011, all existing tax loss carryforwards will never expire but they can offset only 80% of the taxable income of the year.
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 applicable clinical trial. Since the GBM clinical trial is still in Phase 1/2a status, the time frame and uncertainties regarding the outcome of the completion justify the full allowance of deferred tax 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
| At June 30, | At December 31, | |||||||
| 2024 | 2023 | |||||||
| (in Euros) | (Unaudited) | |||||||
| Value added tax (VAT) | € | 420,366 | € | 1,170,634 | ||||
| Research and development tax credit | 766,680 | 833,000 | ||||||
| Advances payments to suppliers | 34,439 | 34,108 | ||||||
| Other current assets | 247,946 | 64,664 | ||||||
| Other prepaids | 193,866 | 378,148 | ||||||
| Total | € | 1,663,297 | € | 2,480,554 | ||||
Value added tax (“VAT”) receivables are linked to purchases. Italian VAT (Imposta sul Valore Aggiunto) applies to the supply of goods and services carried out in Italy by entrepreneurs, professionals, or artists and on imports carried out by anyone. Intra-Community acquisitions are also subject to VAT under certain situations. The Italian standard VAT rate for 2024 and 2023 is 22%. Reduced rates are provided for specifically listed supplies of goods and services. It is carried forward indefinitely and does not expire. The Company reclassified to other non-current assets a portion of the receivable which is expected to be realized beyond 12 months. During the six months ended June 30, 2024, the Company received a VAT refund of approximately €1.7 million, of which approximately €1.3 million related to short-term VAT and approximately €0.4 million related to VAT that was classified as long-term at December 31, 2023. The amount of VAT as of June 30, 2024 is related to the VAT accrued in the same period.
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 €4.0 million at June 30, 2024, which can be carried forward indefinitely and does not expire. However, given the start-up status of the Company, and the fact that it will not be profitable in the foreseeable future (which limits the utilization of the credit), the Company recognized a receivable balance that represents the Company’s best estimate of the amount of tax credit that can be used in offsetting taxes payable by the fourth quarter of 2025. This estimate is consistent with the Company’s most updated cash budget utilization projections approved by the Board in March 2024 and the revised cash forecast as of October 2024. According to the revised cash forecast dated October 2024, the Company’s available cash as of June 30, 2024, together with our investment in short-term marketable securities, is deemed more than sufficient to cover the operating activities through at least November 2025, without additional financing or other management plans.
During the six months ended June 30, 2024 and 2023, the Company utilized approximately €0.4 million to offset certain social contributions and taxes payable. In addition, the recorded benefit for the six months ended June 30, 2024, and June 30, 2023, was approximately €0.4 million, respectively, to offset research and development expenses.
The advance payments to suppliers mainly refer to an advance payment to a supplier whose activities are still ongoing based on a service agreement that provides for a discount on this advance payment on the last invoice that will be issued at the end of the works.
As of June 30, 2024, other current assets were primarily composed of tax credits amounting to approximately €0.2 million and financial claims for accrued interest on ongoing investments, amounting to approximately €53,000. The change compared to the previous period balance was due to the reclassification from long-term to short-term of a €180,000 of tax credit related to Italian Additional Corporate Tax (the “ACE tax”) which, based on the latest updates received from the Italian Revenue Agency, will be recovered in the short term.
The prepaids refer to accrual adjustments for services that have already been fully invoiced and paid, but whose economic usefulness is distributed over multiple periods beyond the current closing period. These costs mainly concern IT services, licenses, insurance, and manufacturing activities. The change in the prepaid balance is primarily influenced by the trend in manufacturing activities performed by the Company’s manufacturing vendor, AGC Biologics, and the amount of the premium for the directors’ and officers’ insurance policy. The most recent renewal of this policy specifically resulted in a significant cost saving, which consequently led to a reduction in the balance of the related prepaid from approximately €0.2 million at June 30, 2023 to approximately €0.1 million at June 30, 2024.
7. Fixed assets, net
Fixed assets consist of the following:
Schedule of fixed assets,net
| At June 30, | At December 31, | |||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| Software (ERP Implementation) | € | 87,800 | € | 87,800 | ||||
| Computers | 37,840 | 35,971 | ||||||
| Furniture and fixtures | 13,005 | 13,005 | ||||||
| Total fixed assets | 138,645 | 136,776 | ||||||
| Less: accumulated depreciation | (75,931 | ) | (53,799 | ) | ||||
| Fixed assets, net | € | 62,714 | € | 82,977 | ||||
For the period ended June 30, 2024 and June 30, 2023, software was €87,800 and includes software customization and development costs related to information technology security infrastructure and the new ERP system.
Equipment consists of computers, and furniture and fixtures of our office space in Milan, Italy. There were no significant purchases, disposals or 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 six months ended June 30, 2024.
8. Other non-current assets
Other non-current assets consist of the following:
Schedule of other non-current assets
| At June 30, | At December 31, | |||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| Value added tax (VAT) | € | 110,774 | € | 630,342 | ||||
| Research and development tax credit | 249,892 | 167,000 | ||||||
| Other non-current assets | 21,004 | 207,218 | ||||||
| Total | € | 381,670 | € | 1,004,560 | ||||
The balance of long-term VAT credit is what remains outstanding after the refund of €0.4 million already received during the six months ended June 30, 2024.
The R&D tax credit long-term portion at June 30, 2024 was approximately €250,000 as compared to €167,000 at December 31, 2023 due to the expected utilization period for the R&D tax credit being adjusted to a timeframe ending November 30, 2025 as per the contingent financial cash projections.
Other non-current assets include the ROU asset for the car lease in the amount of €21,004. The main change in the Other non-current assets balance, compared to the previous period, was due to the reclassification of the €180,000 of ACE tax credit from long-term to short-term following a recent update from the Italian Revenue Agency regarding the expected timing of the related refund.
9. 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% 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, and is recorded by a book reserve. TFR is an unfunded plan. The costs of the retirement benefit obligation are accounted for under the provisions of ASC 715, Compensation – Retirement Benefits.
The amount of the obligation at June 30, 2024 and December 31, 2023 was €196,368 and €164,655, respectively. The increase was due to the increase in personnel costs and as a result of new hires.
10. Shareholders’ equity
The number of the Company’s outstanding ordinary shares at December 31, 2022, was , no par value. All ordinary shares outstanding are held in ledger form with some of the ordinary shares represented by ADSs.
For the six-month period ended June 30, 2023, the Company accrued € as the fair value of stock options granted as per the Plan. (See Note 11. Share-based compensation for more details.)
In July 2023, new ADSs were issued in the Prior ATM Offering, and the Company recorded an increase in the ordinary shares, no par value of €.
For the six-month period from July 1, 2023 to December 31, 2023, the Company accrued € to update the fair value of the granted stock options.
At December 31, 2023, the Company had ordinary shares issued and outstanding with approximately million ordinary shares reserved for the Plan.
In March 2024, new ADSs were issued in the Prior ATM Offering and the Company recorded an increase in the ordinary shares, no par value of €.
For the six-months ended June 30, 2024, the Company accrued € as the fair value of stock options granted as per the Plan. (See Note 11. Share-based compensation for more details)
At June 30, 2024, the Company had ordinary shares issued and outstanding with approximately million ordinary shares reserved for the Plan.
As mentioned in Note 2. Summary of significant accounting policies, to reward the efforts of employees, officers, directors, and certain consultants, and to promote the Company’s growth and development, the Board may approve, upon occasion, various share-based awards.
The Plan was originally approved on May 20, 2021 and was subsequently modified, in June 2023, to extend the final deadline for the issuance of the ordinary shares until December 31, 2035, 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.
At January 1, 2023, there were granted stock options and stock options remaining available for grant.
In March 2023, the Board, as administrator of the Plan, awarded non-qualified stock options (“NSOs”) on shares to the Company’s directors. The NSOs vested monthly over a one (1) year period with a 10-year term. All NSOs were priced based on a 30-day volume weighted average formula, adjusted with the Black-Scholes method, which was determined to be $ per share.
At December 31, 2023, there were granted stock options and stock options remaining available for grant.
In April 2024, NSOs on shares expired. These options had a two (2) year term and were awarded to the Company’s former Chairman in April 2022, according to the terms of a sub-plan called the “2021-2025 Chairman Sub-Plan” (or the “Sub-Plan”) attached to the original Equity Incentive Plan 2021–2025.
At June 30, 2024, there were stock options granted and options available for grant.
The Company calculates the fair value of stock option awards granted to employees and non-employees using the Black-Scholes option-pricing method. If the Company determines 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 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:
| ● | 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. |
| Number of Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value | |||||||||||||
| Outstanding as of January 1, 2023 | 540,523 | € | 4.99 | € | 272,480 | |||||||||||
| Granted | 46,400 | 5.30 | - | |||||||||||||
| Vested and exercised | - | - | - | - | ||||||||||||
| Cancelled or forfeited | - | - | - | - | ||||||||||||
| Outstanding as of December 31, 2023 | 586,923 | € | 4.84 | € | 67,596 | |||||||||||
| Exercisable as of December 31, 2023 | 382,785 | € | 5.11 | € | 33,796 | |||||||||||
| Outstanding, expected to vest as of December 31, 2023 | 204,138 | € | 4.34 | 8.58 | € | 33,800 | ||||||||||
| Outstanding as of January 1, 2024 | 586,923 | € | 4.84 | € | 67,596 | |||||||||||
| Granted | - | - | - | |||||||||||||
| Vested and exercised | - | - | - | - | ||||||||||||
| Cancelled or forfeited | (147,783 | ) | - | - | - | |||||||||||
| Outstanding as of June 30, 2024 | 439,140 | € | 4.53 | € | - | |||||||||||
| Exercisable as of June 30, 2024 | 280,033 | € | 4.58 | € | - | |||||||||||
| Outstanding, expected to vest as of June 30, 2024 | 159,107 | € | 4.44 | 8.05 | € | - | ||||||||||
Schedule of share based compensation expenses
| 2024 | 2023 | |||||||
| Six Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| Research & development expense | € | 37,173 | € | 36,718 | ||||
| Research & development expense - related party | - | - | ||||||
| General & administrative expense | 114,219 | 298,333 | ||||||
| General & administrative expense- related party | 81,376 | 80,381 | ||||||
| Total | € | 232,768 | € | 415,433 | ||||
| Unrecognized expense | € | 747,043 | € | 1,471,743 | ||||
For the six months ended June 30, 2024, and June 30, 2023, the Company recorded € and €, respectively, as the fair value of the stock options granted. The amount of unrecognized expense at June 30, 2024 and June 30, 2023 was € and €, respectively.
There were options granted during the six months ended June 30, 2024. The weighted average grant date fair value of the options granted during the six months ended June 30, 2023 was € per share.
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 six months ended June 30, 2024, and June 30, 2023, there was a weighted average of and shares, respectively, of the Company’s ordinary shares, par value.
12. Accumulated Other Comprehensive Income
Schedule of Accumulated Other Comprehensive Income
| Unrealized gains and losses on available-for-sale debt securities | Foreign Currency Translation Adjustments | Total | ||||||||||
| Changes in Accumulated Other Comprehensive Income | ||||||||||||
| For the Period Ending June 30, 2024 | ||||||||||||
| Unrealized gains and losses on available-for-sale debt securities | Foreign Currency Translation Adjustments | Total | ||||||||||
| Beginning Balance | € | 214,984 | € | 16,158 | € | 231,142 | ||||||
| Adjustment for net gain on marketable securities | (190,228 | ) | (190,228 | ) | ||||||||
| Change in fair value of marketable securities | 125,940 | 125,940 | ||||||||||
| Cumulative translation adjustment | - | (16,081 | ) | (16,081 | ) | |||||||
| Total | € | 150,696 | € | 77 | € | 150,773 | ||||||
Accumulated Other Comprehensive Income relates to marketable securities fair value measurement reserve and cumulative translation adjustment reserve as reported in the above table.
The net realized gain in the six months ended June 30, 2024 from the Company’s investing activity was approximately €0.2 million. The unrealized net gain on marketable securities not matured at June 30, 2024, was approximately €0.1 million. Translation adjustments on investment transactions expressed in U.S. dollars were not material.
The cumulative translation adjustments reserve was not material, and it mainly included the effect of the translation of U.S. dollars held by the U.S. Subsidiary into Euros as the consolidated financial statements currency.
13. Related parties
The Company’s R&D expenses are a combination of third-party expenses, and related party expenses, as detailed below:
Schedule of third party and related party expenses
| Six Months Ended June 30, 2024 | ||||||||||||
| Third Parties | Related Parties | Total | ||||||||||
| Consultants & other third parties | € | 113,498 | € | 303,298 | € | 416,796 | ||||||
| Materials & supplies | 911,246 | - | 911,246 | |||||||||
| Compensation (including share-based) | 349,839 | 329,227 | 679,066 | |||||||||
| Travel & entertainment | 17,589 | - | 17,589 | |||||||||
| Other | 15,693 | - | 15,693 | |||||||||
| Total | € | 1,407,865 | € | 632,525 | € | 2,040,390 | ||||||
| Six Months Ended June 30, 2023 | ||||||||||||
| Third Parties | Related Parties | Total | ||||||||||
| (Unaudited) | ||||||||||||
| Consultants & other third parties | € | 150,402 | € | 72,500 | € | 222,902 | ||||||
| Materials & supplies | 2,464,107 | 660,863 | 3,124,970 | |||||||||
| Compensation (including share-based) | 212,003 | 330,796 | 542,799 | |||||||||
| Travel & entertainment | 27,892 | - | 27,892 | |||||||||
| Other | 3,239 | - | 3,239 | |||||||||
| Total | € | 2,857,643 | € | 1,064,159 | € | 3,921,802 | ||||||
Related party R&D expenses for consultants & other third parties refer mainly to the costs of preclinical and clinical activities charged by OSR. R&D costs for materials & supplies relate mainly to manufacturing costs charged by the Company’s main manufacturing vendor, AGC Biologics. Compensation costs relate to R&D personnel wages, salaries, and share-based compensation including social contribution and other related personnel costs. Travel & entertainment expenses relate mainly to business trips and scientific conferences. Other R&D expenses relate to minor general operating costs.
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
| Six Months Ended June 30, 2024 | ||||||||||||
| Third Parties | Related Parties | Total | ||||||||||
| Compensation (including share-based) | € | 451,903 | € | 698,620 | € | 1,150,523 | ||||||
| Accounting, legal & other professional | 557,049 | - | 557,049 | |||||||||
| Communication & IT related facility | 85,277 | 85,277 | ||||||||||
| Facility & insurance related | 984 | 8,120 | 9,104 | |||||||||
| Consultants & other third parties | 324,306 | - | 324,306 | |||||||||
| Other | 350,752 | 967 | 351,719 | |||||||||
| Total | € | 1,770,271 | € | 707,707 | € | 2,477,978 | ||||||
| Six Months Ended June 30, 2023 | ||||||||||||
| Third Parties | Related Parties | Total | ||||||||||
| (Unaudited) | ||||||||||||
| Compensation (including share-based) | € | 697,228 | € | 673,795 | € | 1,371,023 | ||||||
| Accounting, legal & other professional | 720,989 | - | 720,989 | |||||||||
| Communication & IT related facility | - | - | - | |||||||||
| Facility & insurance related | 2,868 | 8,171 | 11,039 | |||||||||
| Consultants & other third parties | 314,059 | - | 314,059 | |||||||||
| Other | 460,320 | 943 | 461,263 | |||||||||
| Total | € | 2,195,464 | € | 682,909 | € | 2,878,373 | ||||||
The Company’s accounts payable to related parties are comprised as follows:
Schedule of accounts payable to related parties
| At June 30, | At December 31, | |||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| San Raffaele Hospital | € | 189,762 | € | 170,888 | ||||
The Company’s accrued expenses to related parties are comprised as follows:
Schedule of accrued expenses to related parties
| At June 30, | At December 31, | |||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| San Raffaele Hospital | € | 34,306 | € | 413,935 | ||||
| Pierluigi Paracchi | 252,000 | 175,254 | ||||||
| Richard Slansky | 176,812 | 116,738 | ||||||
| Carlo Russo | 235,750 | 155,651 | ||||||
| Total | € | 698,868 | € | 861,578 | ||||
The Company has identified the following related parties:
| ● | Pierluigi Paracchi (director and co-founder of the Company); | |
| ● | Luigi Naldini (co-founder of the Company and chair of the Scientific Advisory Board); | |
| ● | Bernard Rudolph Gentner (co-founder of the Company and member of Scientific Advisory Board); | |
| ● | Carlo Russo (Chief Medical Officer and Head of Development); | |
| ● | Richard Slansky (Chief Financial Officer); and, | |
| ● | Ospedale San Raffaele (co-founder of the Company, shareholder, main service provider for clinical activity and licensor of brands of any product that can be obtained through research). |
These parties could exercise significant influence on the Company’s strategic decisions, behavior, and future plans.
The following is a description of the nature of the transactions between the Company and these related parties:
Pierluigi Paracchi
Mr. Pierluigi Paracchi, is the Company’s Chief Executive Officer, Chairman, as well as co-founder. His current employment arrangement with the Company provides an annual gross salary of €420,000 plus a 40% annual bonus subject to Board approval. Mr. Paracchi also has use of a Company car, for which the Company entered an operating lease agreement that started in 2022.
In March 2023, Mr. Paracchi was paid a bonus of approximately €112,000 (gross amount), related to the activity performed in 2022 and accrued in the same period.
At December 31, 2023, the Company accrued €168,000 for Mr. Paracchi’s bonus (of which €84,000 accrued in the first six months ended June 30, 2023) to reward the activity performed in the same year. At June 30, 2024, the bonus accrued in 2023 was not paid yet. For the six months ended June 30, 2024 the Company accrued €84,000 for Mr. Paracchi bonus for his performance in 2024.
For the six months ended June 30, 2024 and June 30, 2023, the Company expensed approximately €, related to compensation for Mr. Paracchi.
Luigi Naldini/Bernard Rudolph Gentner
Drs. Luigi Naldini and Bernhard Gentner are co-founders of Genenta and part of the Scientific Advisory Board (“SAB”), with Dr. Naldini as Chairman, and Dr. Gentner as a member. The Company has consulting agreements with each of Drs. Naldini and Gentner.
Dr. Naldini has an advisory agreement approved by the Board and he and his staff perform the pre-clinical studies for the Company. The latest consulting agreement with Dr. Naldini was signed on June 20, 2022, which includes an annual fee of €100,000 starting July 1, 2022. As of June 30, 2024, Dr. Naldini billed € and all the issued invoices were paid before June 30, 2024.
Dr. Gentner, like Dr. Naldini, oversees pre-clinical research related to the Company’s platform technology and analyzes clinical biological data. The consulting agreement with Dr. Gentner started on July 1, 2022, and provides fees in the amount of €45,000 per year. As of June 30, 2024, Dr. Gentner billed € and all the issued invoices were paid.
In February 2024, Dr. Gentner entered into an addendum to the consulting agreement in which the Company agrees to pay a total one-time fee of up to €15,000 to conduct research and write and submit a scientific research paper. The agreement provides the fees to be billed progressively if and when the expected research steps are met. At June 30, 2024, only the first step was achieved, billed, and paid in the amount of €.
Carlo Russo
Dr. Carlo Russo serves the Company as Chief Medical Officer and Head of Development and is responsible for the clinical development of Temferon™, the Company’s gene therapy platform. His current employment arrangement is in place with the U.S. Subsidiary, and it provides for an annual gross salary of $500,000, plus a 30% bonus, subject to Board approval.
In March 2023, Dr. Russo was paid a bonus of approximately €112,000 (gross amount), related to the activity performed in 2022 and accrued in the same period.
At December 31, 2023, the Company accrued €156,000 for Dr. Russo’s bonus (of which approximately €84,000 was accrued in the first six months ended June 30, 2023) to reward the activity performed in the same year. At June 30, 2024, the bonus accrued for 2023 was not paid yet. For the six months ended June 30, 2024, the Company accrued €70,000 for Dr. Russo’s bonus for his performance in 2024.
For the six months ended June 30, 2024, and June 30, 2023, the Company expensed approximately €329,000 and €331,000, respectively, related to compensation for Dr. Russo.
Richard Slansky
Mr. Richard Slansky is the Chief Financial Officer of the Company. His current employment arrangement is in place with the U.S. Subsidiary, and it provides an annual gross compensation of $375,000 plus a 30% bonus subject to Board approval.
At December 31, 2023 the Company accrued €116,000 for Mr. Slansky’s bonus (of which approximately €63,000 accrued in the first six months ended June 30, 2023) to reward the activity performed in the same year. At June 30, 2024 the bonus for 2023 was not paid yet. For the six months ended June 30, 2024, the Company accrued €53,000 for Mr. Slansky’s bonus for his performance in 2024.
For the six months ended June 30, 2024, and June 30, 2023, the Company expensed approximately €243,000 and €253,000, respectively, related to compensation for Mr. Slansky.
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 located 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 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 worldwide 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 million for the first lympho-hematopoietic indication; | |
| ● | €0.5 million for the second lympho-hematopoietic indication; and | |
| ● | €0.3 million for the third lympho-hematopoietic indication. |
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 an amount equal to €250,000 pursuant to the Original OSR License Agreement.
Pursuant to the ARLA, as consideration, the Company agreed to pay OSR additional license fees equal to up to €875,000 in total, which are payable on April 20, 2023, December 31, 2023, and upon the Company entering into a sublicense agreement with a third party sublicensee (pursuant to which the Company is entitled to receive an upfront payment in an amount exceeding a specified threshold from such sublicensee) during the period between September 30, 2022 and April 20, 2028 (with most of these additional license fees being triggered upon the Company entering into such a sublicense agreement). In addition, the Company has agreed to pay OSR royalties on a single digit percentage of the net sales of each licensed product. The royalty may be reduced upon the introduction of generic competition or patent stacking, but in no event would the royalty be less than half of what it would have otherwise been, but for the generic competition or patent stacking. The Company also agreed to pay OSR a royalty of our net sublicensing income for each licensed product and to pay OSR certain milestone payments upon the achievement of certain milestone events, such as the initiation of different phases of clinical trials of a licensed product, market authorization application (“MAA”) approval by a major market country, MAA approval in the U.S., the first commercial sale of a licensed product in the U.S. and certain E.U. countries, and achievement of certain net sales levels.
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. The Company is also obligated to carry out its 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 the Company 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). (See Note 14. Commitments and contingencies.)
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. OSR controls enforcement of the patents and know-how rights, at its own expense. In the event that OSR fails to file suit to enforce such rights after notice from the Company, the Company has the right to enforce the licensed technology within the field of use. Both the Company and OSR must consent to settlement of any such litigation, and all monies recovered will be shared, after reimbursement for costs, in relation to the damages suffered by each party, or failing a bona fide agreement between the Company and OSR, on a 50% - 50% basis.
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 fails to pay any of the upfront payments, 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 (each as defined below). 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 June 30, 2024, the cumulative total amount of expenses for the OSR clinical trial activity from inception amounted to approximately €11.0 million and includes the cost for the exercise of the first and the second solid cancer indication option fee of €1.0 million as well as the cost for ARLA fees of €0.4 million.
At June 30, 2024, 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 approximately amounting to €0.2 million, as a whole, is still to be completed.
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 an additional 24-month period. The extension requires payment of an extension fee for each 24-month extension.
At June 30, 2024 the Company recorded and paid approximately €0.3 million for the CP1 SRA studies.
Operating leases
The Company entered into a non-cancelable lease agreement for office space in January 2020. (See Note 14. 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’s obligations by contractual maturity on June 30, 2024:
Schedule of company obligations by contractual maturity
| Payments by Period | ||||||||||||||||||||
| Total | Less than a year | 1 to 3 years | 4 to 5 years | More than 5 years | ||||||||||||||||
| OSR operating leases and office rent | € | 21,267 | € | 15,012 | € | 6,255 | € | - | € | - | ||||||||||
| OSR- ARLA | 166,700 | 166,700 | - | - | - | |||||||||||||||
| AGC manufacturing | 75,985 | 75,985 | - | - | - | |||||||||||||||
| Insurance policies | 11,095 | 6,996 | 4,099 | - | - | |||||||||||||||
| Total | € | 275,047 | € | 264,693 | € | 10,354 | € | - | € | - | ||||||||||
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 arise 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 milestones 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.
CMO and CRO 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 a sufficient level of resources. In particular, consistent with the terms of the Original OSR License Agreement, the ARLA continues to require the Company 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).
The Company incurred €0.9 million and €1.6 million of manufacturing expenses during the first six months ended June 30, 2024, and June 30, 2023, respectively. The cumulative expense to date is €10.1 million, and there is no residual commitment for the Company at June 30, 2024.
The Company has agreed to pay OSR royalties for 4% of the net sales of each licensed product. The royalty may be reduced upon the introduction of generic competition or patent stacking, but in no event would the royalty be less than half of what it would have otherwise been, but for the generic competition or patent stacking. The Company also agreed to pay OSR a royalty of the Company’s net sublicensing income for each licensed product and to pay OSR certain milestone payments upon the achievement of certain milestone events, such as the initiation of different phases of clinical trials of a licensed product, market authorization application (“MAA”) approval by a major market country, MAA approval in the United States, the first commercial sale of a licensed product in the U.S. and certain E.U. countries, and achievement of certain net sales levels.
No events have occurred or have been achieved (and none are considered probable) to trigger any contingent payments under the ARLA during the six months ended June 30, 2024.
AGC Biologics S.p.A.
The AGC agreement dated March 6, 2019 (the “Master Service Agreement”) is non-cancelable, except in the case of breach of contract, and includes a potential milestone of €0.3 million if a phase 3 study is approved by the relevant authority, as well as potential royalty fees between 0.5% and 1.0% depending on the volume of annual net sales of the first commercial and named patient sale of the product. Under the Master Service Agreement, the Company entrusts AGC with certain development activities that will allow the Company to carry out activities related to its clinical research and manufacturing. The Master Service Agreement also includes a technology transfer fee of €0.5 million related to the transfer of the manufacturing know-how and €1.0 million related to the marketability approval by regulatory authorities. The agreement is a “pay-as-you-go” type arrangement with all services expensed in the period the services were performed.
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 used under the Tech Transfer.
In December 2022, the Company signed respectively: (i) the Amendment No. 1 to the Master Service Agreement 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 for raw materials, €40,500 for handling and €24,000 for the stability timepoints. As of June 30, 2024, the project was completed.
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 Nos. 1 and 2 to produce Lentiviral Vector (“LVV”) for ex-vivo application (TIA-126-LV) for an estimated amount, including raw material and third-party costs, of approximately €0.7 million and €1.5 million respectively. At June 30, 2024 the work statement No. 1 was completed, while the work statement No. 2 had approximately €0.2 million to be performed.
In December 2023, the Company entered into purchase orders Nos. 41 and 42 under the Master Service Agreement, for a total amount of approximately €0.2 million. At June 30, 2024, the production activity was completed.
In January 2024, the Company entered into a new project change order No. 1 “For the Process Transfer Agreement,” governed by the term and conditions of the Process Transfer Agreement, to update stage 3 of the Process Transfer Agreement to extend Temferon shelf-life up to 18 months, for a total cost of €8,000.
During the six months ended June 30, 2024, the Company entered into purchase orders Nos. 43, 44 and 45 under the Master Service Agreement, for a total amount of approximately €0.3 million. At June 30, 2024, the production activity was not completed for purchase order No. 43 and not begun for purchase orders Nos. 44 and 45, and was subsequently cancelled in July 2024 as explained below in Note 15. Subsequent events.
In June 2024, the Company entered into a work order for the development studies on frozen apheresis and liquid cultures implementation for an estimated amount including raw materials of approximately €0.3 million.
Operating lease - office rent
On January 1, 2020, the Company began a six-year non-cancelable 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 approximately €15,150, at June 30, 2024, outstanding minimum payments amount to €7,575 through December 2024.
Finance lease
On February 11, 2022, the Company entered a four (4) year auto lease. This lease has been recognized as a finance lease. The automobile underlying the lease agreement is fully covered by insurance policies for the duration of the lease agreement, for a total amount of €27,985. This insurance policy is considered a non-lease component since it represents services provided separately from the auto lease agreement. Therefore, it is accounted for in insurance expense in the Consolidated Statement of Operations and Comprehensive Loss when occurred. At June 30, 2024, the outstanding payments for insurance expenses related to the automobile under lease amounted to approximately €11,000.
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.
15. Subsequent events.
AGC Biologics S.p.A.
In July 2024:
| - | the Company signed a purchase order with AGC, named ‘Bresso Preparatory Activities’, specifically for a one-time fee applicable to all ongoing activity programs and intended for the performance of the same manufacturing activities for €0.1 million; | |
| - | the Company signed a purchase order with AGC, No.46, for a total amount of approximately €0.1 million for manufacturing activity; | |
| - | the Company cancelled purchase orders with AGC, Nos. 44 and 45, and, as a consequence, the Company will incur a cancellation fee of approximately €112,000; and | |
| - | on September 19, 2024, an Amendment to the Master Service Agreement was signed with AGC. The purpose of the amendment was to extend the term of the Master Service Agreement to June 30, 2025. The amendment was considered effective retroactive from March 5, 2024, the day on which the Master Service Agreement expired, to cover the preceding period during which the same MSA continued to be operating. | |
| In September 2024: | ||
| - | the Company signed two purchase orders with AGC, GU_01 and GU_02, for approximately €159,000 total, for the manufacturing activity scheduled for November to be performed by AGC for the first two patients of the new TEM-GU study. | |
| In October 2024: | ||
| - | the Company signed a purchase order with AGC, No.47, for a total amount of approximately €0.1 million for manufacturing activity. |
Share-based compensation
In July 2024, the Board, as the administrator of the Equity Incentive Plan 2021-2025, awarded NSOs on shares to the Company’s directors, officers, and employees. The director NSOs vest immediately with a -year term. The officer and employee NSOs have a -year term and vest monthly over , except that employees with less than one year of service have a one-year cliff vesting from the date of hire, and then monthly vesting thereafter. All options have an exercise price utilizing the stock price at the date of grant of $3.083 per share.
Status of proposed Renal Cell Cancer trials
In October 2024, the Company announced that the Agenzia Italiana del Farmaco approved a new Phase 1 clinical trial for metastatic Renal Cell Cancer. The Company expects to commence the trial in the fourth quarter of 2024.
In October 2024, the Company also entered into an agreement with OSR to conduct an open-label phase 1/2 clinical trial in Renal Cell Cancer. The study is designed to evaluate the safety, biological response, and efficacy of a single dose of Temferon (autologous hematopoietic stem and progenitor cells enriched with CD34+ and genetically modified with human Interferon-α2) in patients with metastatic renal carcinoma.
