Related parties | 12. 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 Six Months Ended June 30, 2022 Third Parties Related Parties Total (in Euros) (Unaudited) Consultants & other third parties € 298,265 € 40,000 € 338,265 Materials & supplies 837,098 - 837,098 Compensation (including share-based) 162,167 215,761 377,928 Travel & entertainment 65,938 - 65,938 Other 21,350 - 21,350 Total € 1,384,818 € 255,761 € 1,640,579 Six Months Ended June 30, 2021 Third Parties Related Parties Total (in Euros) (Unaudited) Consultants & other third parties € 525,978 € 1,541,526 € 2,067,504 Materials & supplies 717,905 - 717,905 Compensation (including share-based) 221,900 179,480 401,380 Travel & entertainment 10,445 - 10,445 Other 2,000 - 2,000 Total € 1,478,228 € 1,721,006 € 3,199,234 Research and development expenses mainly refer to LVV (Lentiviral Vector for Gene therapy) production activities and to preclinical and clinical activities mainly at the San Raffaele Hospital in Milan. Specifically, the related party research and development expenses refer to the costs of preclinical and clinical activities charged by San Raffaele Hospital. 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 30,2022 Third Parties Related Parties Total (In Euros) (Unaudited) Compensation (including share-based) € 522,012 € 421,558 € 943,570 Accounting, legal & other professional 376,642 - 376,642 Facility & insurance related 3,873 7,457 11,330 Consultants & other third parties 384,243 - 384,243 Other 794,248 3,525 797,773 Total € 2,081,018 € 432,540 € 2,513,558 Six Months Ended June 30,2021 Third Parties Related Parties Total (In Euros) (Unaudited) Compensation (including share-based) € 258,514 € 150,000 € 408,514 Accounting, legal & other professional 181,354 - 181,354 Facility & insurance related 1,712 7,197 8,909 Consultants & other third parties 127,988 - 127,988 Other 115,471 - 115,471 Total € 685,039 € 157,197 € 842,236 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, 2022 2021 (in Euros) (Unaudited) San Raffaele Hospital € 265,616 € 25,047 Carlo Russo 8,208 - Richard Slansky 3,830 - Total € 277,654 € 25,047 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 2022 2021 (in Euros) (Unaudited) San Raffaele Hospital (OSR) € 172,359 € 19,201 Executive bonus - 25,000 XDG Biomed - 34,438 Financial consultant - 53,502 Total € 172,359 € 132,141 The increase in San Raffaele Hospital (OSR) account payables balance and accrued expenses compared to December 31, 2021, was due to a delay in the invoicing process by OSR. The Company has identified the following related parties: ● Pierluigi Paracchi ● Luigi Naldini ● Bernard Rudolph Gentner ● Carlo Russo ( ● Richard Slansky ● Spafid S.pA. ( 5 ● 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, President and Chairman of the Company prior to the conversion, is the current Chief Executive Officer, Vice-Chairman, as well as co-founder. His annual compensation, until December 16, 2021, amounted to € 250,000 50,000 420,000 20 In April 2022, Mr. Paracchi received a bonus of € 50,000 23,000 37,000 For the six months ended June 30, 2022, the Company expensed € 248,242 150,000 For the six months ended June 30, 2022, the Company accrued approximately € 14,000 Luigi Naldini/Bernard 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 agreement with Dr. Naldini, signed in 2019, in place during the six months ended June 30, 2022, provided for an annual fee of € 50,000 25,000 Dr. Gentner, like Dr. Naldini, oversees pre-clinical research related to the Company’s platform technology. In addition, he analyzes clinical biological data. The last agreement with Dr. Gentner, which is still in force, was signed in 2017. His annual fee is € 30,000 15,000 XDG Biomed LLC/Carlo Russo XDG Biomed is the LLC of Dr. Carlo Russo. Dr. Russo has a single contract signed by XDG and the Company that was 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 pre-IPO. Dr. Russo is responsible for the clinical development of Temferon™, the Company’s gene therapy platform. The recurring fee for Dr. Russo’s services until the IPO date (i.e., December 15, 2021) was € 300,000 50,000 500,000 30 For the six months ended June 30, 2022, and June 30, 2021, the Company expensed € 215,761 175,000 In April 2021, Dr. Russo was awarded a stock option grant, which was immediately vested and exercised, with a value accrued in the Consolidated Statement of Operations and Comprehensive Loss of € 179,480 At December 31, 2021, € 25,000 Richard Slansky Mr. Richard Slansky is the Chief Financial Officer of the Company. He was engaged in late 2020 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. During the six months ended June 30, 2021, by the advisory agreement, Mr. Slansky invoiced Genenta for € 42,224 In April 2021, Mr. Slansky was awarded a stock option grant, which was immediately vested and exercised, with value accrued in the Company’s Consolidated Statement of Operations and Comprehensive Loss of € 54,388 At December 31, 2021, a bonus was accrued, after the success of the IPO, in the amount of $ 50,000 Under the new employment agreement, which started on November 1, 2021, Mr. Slansky is entitled to receive a gross annual compensation of $ 300,000 30 During the six months ended June 30, 2022, the Company recorded a total cost for Mr. Slansky amounting to € 173,317 Spafid SpA Spafid is a Genenta shareholder with an ownership greater than 5 For the six months ended June 30, 2022, Spafid invoiced the Company € 3,525 OSR – San Raffaele Hospital OSR - San Raffaele Hospital is a co-founder of the Company and a shareholder with an ownership greater than 5 License Agreement The Company has a License Agreement with OSR entered in December 2014, for the exclusive use of different patents. In particular, OSR granted the Company an exclusive, world-wide, royalty bearing license under certain technology to conduct research and develop, make, use, import and sell licensed products. The License Agreement covers patents and patent applications, as well as proprietary technologies. The Company’s rights to use these patents and patent applications and to utilize the inventions claimed in these licensed patents are subject to the continuation of, and the Company’s compliance with, the terms of the license agreement. Based on the preclinical studies conducted by OSR, in particular by its SR-TIGET Institute (San Raffaele Telethon Institute for Gene Therapy), on a specific gene therapy strategy with respect to lympho-hematopoietic indication and/or solid cancer indication, the Company decided to develop a new therapy to treat cancer through a cell and gene therapy strategy. The “Field of Use” as defined in the License Agreement is: a) Lympho-Hematopoietic Indication 1 b) Solid Cancer Indication. The agreement provided for an upfront fee of € 250,000 ● option fee on the first indication = € 1.0 0.5 ● option fee on the second indication = € 0.5 ● option fee on the third indication = € 0.3 ● option fee on any additional indications = no license fee. 1 In addition, the Company is obligated make payments on milestones depending on the Field of Use (as defined in the agreement) and pay royalties of 4 In connection to the License Agreement, the Company engaged OSR to provide certain research activities regarding the Licensed Products in the Field of Use, based on a mutually agreed study plan and utilizing the extensive resources at OSR. (See Note 13. Commitments and contingencies.) In consideration of the research activities provided by OSR, the Company agreed to pay scientific collaboration research fees in advance. In December 2014, the Company and OSR signed a Scientific Collaboration Agreement and subsequently modified the Agreement with Research Addenda 1, 2 and 3 in 2016, 2017 and 2018, respectively. During the six months ended June 30, 2022 and June 30, 2021, there were no costs incurred for the above activities. The protocol TEM-GBM_001 received approval by national Competent Authorities in September 2018 and recruited the first patient in April 2019. License Agreement Amendment #2 In February 2019, the Company and OSR entered into Amendment #2 of the License Agreement to conduct a clinical trial according to the protocol TEM-GBM_001 and EudraCT 2018-001404-11 entitled: “A phase I/IIa dose escalation study evaluating the safety and efficacy of autologous CD34+ enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-α2 in patients with GBM who have an unmethylated O-6-methylguanine-DNA methyltransferase gene promoter.” In Amendment #2, the Company and OSR also revised the license fee requirement for the first Solid Cancer indication (GBM). In relation to the GBM trial, the Company and OSR agreed that the Company would be obligated to pay OSR the € 1.0 0.3 0.8 Under Amendment #2, the Company is obligated to cover the costs of the study-related procedures performed on the patients recruited in the Trial, according to periodic study reports delivered by OSR. License Agreement Amendment #3 In December 2020, the Company and OSR entered into Amendment #3 of the License Agreement: The initial € 1.0 0.5 In summary, the Amendment #3 formalized the new arrangement as follows: - exercise of option fee on the first solid cancer indication = € 0.5 - commitment to enter into a Sponsored Research Agreement by February 2021; and, - exercise of option fee on the second indication = € 0.5 At June 30, 2022, no milestones were achieved related to any indication, as provided by License Agreement and subsequent amendments; therefore, no such payments were due to OSR. The Company paid € 1.25 OSR may terminate the Company’s rights as to certain fields of use for the Company’s failure to develop (a) with respect to a solid cancer indication, upon third anniversary of the date the Company exercised such option, if the Company has not filed an IND with respect to such optioned solid cancer indication specifically, as to GBM, the Company is required to file an IND regarding Temferon for GBM prior to February 2022, or (b) with respect to a lympho-hematopoietic indication, on the earlier of (i) the fifth anniversary of the initiation (first patient dosed) of the first human clinical trial for a licensed product in any lympho hematopoietic indication or solid cancer indication if a patient has not been dosed with a licensed product in a Phase 3 clinical trial, or (ii) September 1, 2025. License Agreement Amendment #4 On September 28, 2021, the fourth amendment to the License Agreement was signed with the aim to extend the deadline for the definition of the second Solid Cancer Indication. If the Company is not able to obtain approval of the Regulatory Authorities to initiate a human clinical trial in any country with respect to solid liver cancer on or before September 30, 2022, then the Company shall have the right, at no additional cost, to convert the option exercise for the second Solid Cancer Indication to an indication (the “Alternate Indication”) other than solid liver cancer, upon written notice to OSR, such notice is to be delivered to OSR within September 30, 2022. Under the amendment, the Company will be entitled to exercise the Option set forth above with respect to any other Solid Cancer Indication for the remainder of the Option Period that will expire on December 23, 2022, and shall not be subject to further extensions. At June 30, 2022, the cumulative total amount of expenses for the OSR clinical trial activity from inception amounted to approximately € 9.0 1.0 License Agreement Amendment #5 On January 22, 2022, the fifth amendment to the License Agreement was signed with the aim to clarify certain terms. It has been stated that solely with respect to GBM, “IND” means an investigational new drug application (including any amendment or supplement thereto) submitted to the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations. IND shall include any comparable filing(s) outside the United States of America for the investigation of any product in any other country or group of countries (such as a Clinical Trial Application, or CTA, in the European Union). In addition, with respect to Licensed Products for GBM, Genenta commits to carry out a Phase III Clinical Trial also in US. With respect to GBM, Genenta shall pay to OSR an additional Milestone Payment equal to € 350,000 Moreover with regards to termination rights, if Genenta has not filed an IND with respect to such Solid Cancer Indication within three (3) years from the date of the exercise of the option (or, in relation to GBM, has not dosed the first patient with a Licensed Product for GBM in a Phase III Clinical Trial started in the US within 72 months from the first patient being dosed in the first human clinical trial of such applicable Licensed Product for GBM), the termination rights shall be limited to such Licensed Product in the Terminated Solid Cancer Indication. Any further activity on such Licensed Product in the Terminated Solid Cancer Indication shall be immediately discontinued by Genenta. As of June 30, 2022, no milestones were achieved related to any indication, as provided by the License Agreement; therefore, no payments were due to OSR, nor other contingencies exist Research Funding Agreement In March 2019, the Company and OSR entered a Research Funding Agreement to conduct a clinical trial according to the multiple myeloma protocol, TEM-MM-101 and EudraCT 2018-001741-14, entitled “A Phase I/II dose escalation study evaluating safety and activity of autologous CD34+ enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-α2 in multiple myeloma patients with early relapse after intensive front-line therapy.” This agreement required OSR to perform certain clinical procedures and exploratory analyses on the study population, as per the protocol approved by the relevant competent authorities. The Company was required to fund the costs of the study-related procedures performed on patients recruited in the Trial, according to periodic study reports delivered by OSR. TEM-MM-101 received approval by national Competent Authorities in November 2018 and the first TEM-MM-101 trial patient was enrolled in August 2019. The Company discontinued the multiple myeloma program in early 2021 due to the relatively small number of eligible patients, and the highly competitive MM landscape. (See Note 13.) Sponsor Research Agreement (SRA) As stated above, in exchange for a reduction in the first Solid Cancer indication option fee from € 1.0 0.5 0.5 1.0 0.5 ● Research 1: Additional preclinical mouse model studies directed to identify Temferon effectors cells (transduced Tie2-expressing cells) and to test Temferon in combination with CAR-T in a GBM mouse model; and, ● Research 2: Additional exploratory analyses, including single cell sequencing, to be conducted on samples collected from patients belonging to TEM-GBM_001 clinical trial aimed to deepen Temferon mechanism of action and get a broader insight on its biological activity in humans. For the six months ended June 30, 2022, and June 30, 2021, the Company paid and expensed € 375,000 500,000 Amendment #01 to the Agreement of March 2, 2019 On April 27, 2022 OSR and Genenta signed this Amendment #01 as an amendment to the Agreement for Clinical Trials called: “ Phase I/IIa clinical trial to assess the safety and efficacy of increasing doses of autologous CD34+ hematopoietic stem cells genetically modified with a lentiviral vector encoding for the human interferon-alpha2 gene in patients with Glioblastoma Multiforme with unmethylated MGMT gene promoter ● TEM-MM unspent budget to be reallocated to the TEM-GBM study: ● Investigator € 105,000 ● Data Manager € 92,500 ● Total € 197,500 During the six months ended June 30, 2022, the Company recorded expenses of € 105,551 Operating leases The Company entered into a non-cancelable lease agreement for office space in January 2020. (See Note 13. Commitments and contingencies.) |