Related parties | 13. Related parties The Company’s R&D 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 R&D R&D 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 ● Luigi Naldini ● Bernard Rudolph Gentner ● Carlo Russo ● Richard Slansky and, ● Ospedale San Raffaele 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 In March 2023, Mr. Paracchi was paid a bonus of approximately € 112,000 At December 31, 2023, the Company accrued € 168,000 84,000 84,000 For the six months ended June 30, 2024 and June 30, 2023, the Company expensed approximately € 300,000 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 50,000 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 22,500 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 5,000 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 30 In March 2023, Dr. Russo was paid a bonus of approximately € 112,000 At December 31, 2023, the Company accrued € 156,000 84,000 70,000 For the six months ended June 30, 2024, and June 30, 2023, the Company expensed approximately € 329,000 331,000 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 30 At December 31, 2023 the Company accrued € 116,000 63,000 53,000 For the six months ended June 30, 2024, and June 30, 2023, the Company expensed approximately € 243,000 253,000 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 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 ● € 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 an 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. 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). 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 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). At June 30, 2024, the cumulative total amount of expenses for the OSR clinical trial activity from inception amounted to approximately € 11.0 1.0 0.4 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 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 Operating leases The Company entered into a non-cancelable lease agreement for office space in January 2020. (See Note 14. |