Related parties | 13. Related parties The Company’s research and development expenses are a combination of third-party expenses, and related party expenses, as detailed below: Schedule of third party and related party expenses For the Year Ended December 31, 2023 Third Parties Related Parties Total (in Euros) Consultants & other third parties € 305,289 € 1,331,166 € 1,636,455 Materials & supplies 3,639,920 - 3,639,920 Compensation (including share-based) 467,557 645,932 1,113,489 Travel & entertainment 44,243 - 44,243 Other 39,965 369 40,334 Total € 4,496,974 € 1,977,467 € 6,474,441 For the Year Ended December 31, 2022 Third Parties Related Parties Total (in Euros) Consultants & other third parties € 804,341 € 726,082 € 1,530,423 Materials & supplies 2,790,982 - 2,790,982 Compensation (including share-based) 412,085 580,196 992,281 Other 25,276 - 25,276 Total € 4,032,684 € 1,306,278 € 5,338,962 For the Year Ended December 31, 2021 Third Parties Related Parties Total (in Euros) Consultants & other third parties € 946,156 € 711,464 € 1,657,620 Materials & supplies 1,231,019 - 1,231,019 Compensation (including share-based) 284,957 214,892 499,849 Travel & entertainment - 596 596 Other 1,593 - 1,593 Total € 2,463,725 € 926,952 € 3,390,677 Research and development (related party) expenses during the years ended December 31, 2023, 2022, and 2021, mainly relate to the clinical trial activity done as per the agreement with the OSR - San Raffaele Hospital. The increase in research and development expenses related parties for the year ended December 31, 2023, compared to the year ended December 31, 2022, was due to the increase in the number of treated patients and related clinical trial activities. Furthermore, the increase was also determined by the reduction in the offsetting effect of research and development tax credits. The Company recorded research and development expenses of approximately € 6.5 6.9 0.4 5.3 6.0 0.7 In 2021, the Company recorded research and development expenses of approximately € 3.4 4.6 1.2 The Company’s general and administrative expenses are also a combination of third-party and related party expenses, as detailed below: Schedule of third party and general and administrative expenses For the Year Ended December 31, 2023 Third Parties Related Parties Total (In Euros) Compensation (including share-based) € 1,218,299 € 1,317,068 € 2,535,367 Accounting, legal & other professional 1,026,534 - 1,026,534 Communication & IT related Facility 166,416 166,416 Facility & insurance related 6,180 15,731 21,911 Consultants & other third parties 610,103 - 610,103 Other 896,018 2,152 898,170 Total € 3,923,550 € 1,334,951 € 5,258,501 For the Year Ended December 31, 2022 Third Parties Related Parties Total (in Euros) Compensation (including share-based) € 1,293,880 € 1,268,974 € 2,562,854 Accounting, legal & other professional 781,817 - 781,817 Communication & IT related 171,380 - 171,380 Facility & insurance related 1,241,692 14,815 1,256,507 Consultants & other third parties 593,788 - 593,788 Other 331,824 6,860 338,684 Total € 4,414,381 € 1,290,649 € 5,705,030 For the Year Ended December 31, 2021 Third Parties Related Parties Total (in Euros) Compensation (including share-based) € 353,177 € 567,624 € 920,801 Accounting, legal & other professional 390,134 - 390,134 Communication & IT related 52,230 - 52,230 Facility & insurance related 71,181 14,399 85,580 Consultants & other third parties 675,688 - 675,688 Other 164,468 7,695 172,163 Total € 1,706,878 € 589,718 € 2,296,596 There were no significant changes in general and administrative expenses related parties during the year ended December 31, 2023, compared to the year ended December 31, 2022. General and administrative expenses, other than related party, decreased mainly because of the decrease in the Company’s limited liability insurance cost, aka director and officer (“D&O”) insurance. The increase in general and administrative expenses related parties during the year ended December 31, 2022, compared to the year ended December 31, 2021 was mainly due to the increase in management compensation. General and administrative expenses, other than related party, increased due to the increase in D&O insurance and to the increase in legal and audit fees as result of the post IPO administrative and compliance activities. The Company’s accounts payable to related parties are comprised as follows: Schedule of accounts payable to related parties 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) San Raffaele Hospital (OSR) € 170,888 € 150,206 € 25,047 Pierluigi Paracchi - - - Carlo Russo - 198 - Richard Slansky - 1,584 - Total € 170,888 € 151,988 € 25,047 The Company’s accrued expenses to related parties are comprised as follows: Schedule of accrued expenses to related parties 2023 2022 2021 At December 31, 2023 2022 2021 (in Euros) San Raffaele Hospital (OSR) € 413,935 € 176,559 € 19,201 Pierluigi Paracchi 175,254 112,501 25,000 Richard Slansky 116,738 81,369 53,502 Carlo Russo 155,651 118,778 34,438 Total € 861,578 € 489,207 € 132,141 The Company has identified the following related parties: ● Pierluigi Paracchi ● Luigi Naldini ● Bernhard Rudolph Gentner ● Carlo Russo ● Richard Slansky ● OSR - San Raffaele Hospital The following is a description of the nature of the transactions between the Company and these related parties: Pierluigi Paracchi Mr. Pierluigi Paracchi, President and Chairman of the Company prior to the conversion, is the current Chief Executive Officer, Vice-Chairman, as well as co-founder. His current employment arrangement with the Company provides an annual gross salary of € 420,000 40 In April 2022, Mr. Paracchi received a bonus of € 60,000 23,000 37,000 20 40 For the year ended December 31, 2023, and 2022, the Company expensed approximately € 692,000 624,000 At December 31, 2023 the Company accrued € 168,000 112,501 Luigi Naldini/Bernhard Rudolph Gentner Drs. Naldini and Gentner are co-founders of Genenta and part of the SAB – Scientific Advisory Board, with Dr. Naldini as Chairman, and Dr. Gentner as a member. Dr. Naldini has an advisory agreement approved by the Board of Directors and performs the pre-clinical studies for the Company. In particular, the pre- clinical experiments are in solid tumor indications. The last consulting agreement with Dr. Naldini was signed on June 20, 2022, which included an annual fee of € 100,000 100,000 Dr. Gentner, like Dr. Naldini, oversees pre-clinical research related to the platform technology. In addition, he analyzes clinical biological data. The last agreement with Dr. Gentner, started on July 1, 2022 and provided fees in the amount of € 45,000 45,000 Carlo Russo – former XDG Biomed LLC XDG Biomed is the LLC of Dr. Carlo Russo. Dr. Russo has a single contract signed by XDG and the Company that has been approved by the Board of Directors and was subject to multiple amendments. In particular, Dr. Russo, via XDG, served as the Company’s Chief Medical Officer and Head of Development. Dr. Russo is responsible for the clinical development of Temferon™, the Company’s gene therapy platform. The applicable recurring fees until the IPO date was € 300,000 50,000 500,000 30 For the year ended December 31, 2023, and 2022, the Company expensed approximately € 592,000 580,000 At December 31, 2023, the Company accrued approximately € 156,000 112,000 Richard Slansky Mr. Slansky is the Chief Financial Officer of the Company. Prior the IPO, he was engaged by the Company to assist with financial, accounting and audit support under an advisory agreement until the end of October 2021. On November 1, 2021, he joined the Company full time and has been employed as Chief Financial Officer. Under the new employment agreement, Mr. Slansky is entitled to receive a gross annual compensation of $ 300,000 30 375,000 30 For the year ended December 31, 2023, and 2022, the Company expensed approximately € 456,000 445,000 116,000 77,000 In July 2022, Mr. Slansky was awarded a stock option grant and part of it was immediately vested, with value accrued into the Company’s Consolidated Statements of Operations and Comprehensive Loss of approximately € 201,000 OSR – San Raffaele Hospital OSR - San Raffaele Hospital is a co-founder of the Company, and the Company is a corporate and research spin-off of OSR. OSR is one of the leading biomedical research institutions in Italy and Europe, with a 45-year history of developing innovative therapies and procedures. The Company has agreements to license technology, to perform research, pre-clinical and clinical activities, as well as to lease facilities and obtain certain other support functions. The Company’s headquarters is currently in an OSR facility. Amended and Restated OSR License Agreement The Company entered into an Amended and Restated License Agreement (the “ARLA”) with OSR in March 2023. The ARLA replaced the Company’s original license agreement originally entered into with OSR on December 15, 2014, as subsequently amended on March 16, 2017, February 1, 2019, December 23, 2020, September 28, 2021, January 22, 2022, September 29, 2022, and December 22, 2022 (the “Original OSR License Agreement”). The effectiveness of the ARLA was subject to Italy’s Law Decree No. 21 of March 15, 2012 (i.e., the Italian Golden Power regulations), as subsequently amended and supplemented, and would not become effective until the applicable Italian governmental authority consented to the ARLA. On April 20, 2023, such consent was received and the ARLA became effective. Pursuant to the terms of the ARLA, OSR has granted the Company an exclusive, royalty-bearing, non-transferrable (except with the prior written consent of OSR), sublicensable, worldwide license, subject to certain retained rights, to (1) certain patents, patent applications and existing know-how for the use in the field(s) of Interferon (“IFN”) gene therapy by lentiviral based-hematopoietic stem and progenitor cells (“HSPC”) gene transfer with respect to any solid cancer indication (including glioblastoma and solid liver cancer) and/or (b) any lympho-hematopoietic indication for which the Company exercises an option (described below); and (2) certain gene therapy products (subject to certain specified exceptions related to replication competent viruses) developed during the license term for use in the aforementioned field(s) consisting of any lentivirals or other viral vectors regulated by miR126 and/or miR130 and/or other miRs with the same expression pattern as miR126 and miR130 in hematopoietic cells for the expression of IFN under the control of a Tie2 promoter. Lympho-hematopoietic indication means any indication related to lympho-hematopoietic malignancies and solid cancer indication means any solid cancer indication (e.g., without limitation, breast, pancreas, colon cancer), with each affected human organ counting as a specific solid cancer indication. The rights retained by OSR, and extending to its affiliates, include the right to use the licensed technology for internal research within the field(s) of use, the right to use the licensed technology within the field(s) of use other than in relation to the licensed products, and the right to use the licensed technology for any use outside the field(s) of use, but subject to the options described below. In addition, the Company granted OSR a perpetual, worldwide, royalty-free, non-exclusive license to any improvement generated by the Company with respect to the licensed technology, to conduct internal research within the field(s) of use directly, or in or with the collaboration third parties; and, for any use outside the field(s) of use, in which case the license is sublicensable by OSR. Finally, the world-wide rights for the field(s) of use granted to the Company regarding the Lentigen know-how are non-exclusive and cannot be sublicensed due to a pre-existing nonexclusive sublicense to these rights between OSR and GlaxoSmithKline Intellectual Property Development Limited. Pursuant to the ARLA, the Company has an exclusive option exercisable until April 20, 2026 to any OSR product improvements at no additional cost, which could be useful for the development and/or commercialization of licensed products in the field of use. The Company also has an exclusive option exercisable until April 20, 2026 (the “LHI Option Period”) to any lympho-hematopoietic indication(s) to be included as part of the field of use, on an indication-by-indication basis, subject to the payment of specified option fees and milestone payments: ● € 1.0 ● € 0.5 ● € 0.3 No option fee is due for the fourth lympho-hematopoietic indication and any subsequent lympho-hematopoietic indications. The Company has the right to extend the LHI Option Period twice for additional 12-month periods, subject to the payment of specified extension fees. Prior to the effective date of the ARLA, the Company paid OSR an upfront fee in amount equal to € 250,000 Pursuant to the ARLA, as consideration, the Company agreed to pay OSR additional license fees equal to up to € 875,000 As part of the ARLA, the Company has agreed to use reasonable efforts to involve OSR in Phase I clinical trials for licensed products in the field of use, subject to OSR maintaining any required quality standards and providing its services on customary and reasonable terms and consistent with then-applicable market standards. We are also obligated to carry out our development activities using qualified and experienced professionals and sufficient level of resources. In particular, consistent with the terms of the Original OSR License Agreement, the ARLA continues to require us to invest (a) at least €5,425,000 with respect to the development of the licensed products, and (b) at least €2,420,000 with respect to the manufacturing of such licensed products (subject to certain adjustments) OSR maintains control of the preparation, prosecution and maintenance of the patents licensed. The Company is obligated to pay those costs unless additional licensees benefit from these rights, in which case the cost will be shared pro rata The ARLA expires upon the expiry of the “Royalty Term” for all licensed products and all countries, unless terminated earlier. The Royalty Term begins on the first commercial sale of a licensed product in each country, on a country by country basis, and ends upon the later of the (a) expiration of the commercial exclusivity for such product in that country (wherein the commercial exclusivity refers to any remaining valid licensed patent claims covering such licensed product, any remaining regulatory exclusivity to market and sell such licensed product or any remaining regulatory data exclusivity for such licensed product), and (b) 10 years from the first commercial sale of such licensed product in such country. The parties may terminate the agreement in the event the other party breaches its obligations therein, which termination shall become effective 60 business days following written notice thereof to the breaching party. The breaching party shall have the right to cure such breach or default during such 60 business days. OSR may terminate the agreement for failure to pay in the event that the Company fail to pay any of the upfront payment, additional license fees, sublicensing income or milestone payments within 30 days of due dates for each. In addition, OSR may terminate (with a 60-business-day prior written notice) the Company’s rights as to certain fields of use for the Company’s failure to achieve certain development milestones for specified licensed products within certain time periods, which may be subject to extension. In addition, OSR may terminate the agreement in the event that commercialization of a licensed product is not started within 24 months from the grant of both (i) the MAA approval and (ii) the pricing approval of such licensed product, provided that such termination will relate solely to such licensed product and to such country or region to which both such MAA approval and pricing approval were granted. Amendment to OSR Amended and Restated License Agreement On September 28, 2023, the Company and OSR entered into an amendment to the ARLA, whereby the Company and OSR agreed that the Company had fulfilled the obligations as set forth in the ARLA specific to Candidate Products 1 pursuant to the CP1 SRA. Furthermore, the amendment provides that the Company and OSR have no further obligations to negotiate and execute a sponsored research agreement for the performance of feasibility studies related to certain gene therapy products consisting of any lentiviral vectors regulated by miR126 and/or miR130 and/or other miRs with the same expression pattern as miR126 and miR130 in hematopoietic cells for the expression of cytokines and their variants (other than IFN or in addition to IFN) under the control of a Tie2 promoter, either alone or in combination with any immunotherapy (“Candidate Products 2”). Notwithstanding the removal of the obligation to enter into a sponsor research agreement with regards to Candidate Products 2, OSR granted the Company an exclusive option, to be exercised by sending written notice to OSR on or before September 30, 2025, to include certain intellectual property related to Candidate Products 2 and Candidate Products 2 as part of the licensed patents and licensed products under the ARLA. The option fee and the Company’s fee to extend the option period, if necessary, remain consistent with the prior fees to those costs reflected in the ARLA specific to Candidate Products 2. OSR will also have the right to prepare, file and prosecute patents and patent applications with respect to the results of Candidate Products 2. The amendment provides that the costs of the foregoing activities will be borne by the Company. At December 31, 2023, the cumulative total amount of expenses for the OSR clinical trial activity from inception amounted to approximately € 10.8 1.0 0.4 At December 31, 2023, there were no pending activities with OSR related to any agreement in place prior to the ARLA effective date, except for the project called “TEM-MM unspent budget reallocated to the TEM-GBM study”, for which the last tranche of activities corresponding to the 20% of the total project amounting to € 197,500 OSR Sponsor Research Agreement On August 1, 2023, the Company entered into a Sponsored Research Agreement (“CP1 SRA”), which was contemplated under the ARLA, pursuant to which the Company will fund feasibility studies for certain gene therapy products consisting of any lentiviral vectors regulated by miR126 and/or miR130 and/or other miRs with the same expression pattern as miR126 and miR130 in hematopoietic cells for the expression of IFN under the control of a Tie2 promoter, in combination with any immunotherapy (“Candidate Products 1”), along with three additional research projects, to be conducted at OSR. If OSR determines that additional funds are needed, OSR will inform the Company and provide an estimate for completing the research. During the period from the date of execution from the CP1 SRA until six months from the last report delivered to the Company under the CP1 SRA (the “CP1 Option Period”), the Company has the exclusive option to include certain intellectual property related to Candidate Products 1 and Candidate Products 1 as part of the licensed patents and licensed products under the ARLA. To exercise this option, the Company must pay an option exercise fee. The Company also has the right to extend the CP1 Option Period twice for additional 24-month periods. The extension requires payment of an extension fee for each 24-month extension. At December 31, 2023 the Company recorded and paid € 250,000 Operating leases The Company entered into a non-cancelable lease agreement for office space in January 2020 (see Note 14 below). |