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Related parties
 6 Months Ended
Jun. 30, 2025
Related Party Transactions [Abstract]  
Related parties

17. Related parties

 

The Company’s R&D expenses are a combination of third-party expenses, and related party expenses, as detailed below:

 

 

   Third parties   Related parties   Total 
   Six Months Ended June 30, 2025 
   Third parties   Related parties   Total 
     
Consultants & other third parties  €113,224   €77,500   €190,724 
Materials & supplies   890,580    -    890,580 
Compensation (including share-based)   344,999    8,399    353,398 
Travel & entertainment   14,935    -    14,935 
Other   5,098    -    5,098 
Total  €1,368,836   €85,899   €1,454,736 

 

   Third parties   Related parties   Total 
   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 

 

Related party R&D expenses for consultants & other third parties refer mainly to the costs of preclinical and clinical activities charged by OSR. The decrease compared to the previous period is mainly due to the greater offsetting effect of these costs with the tax benefit resulting from the revaluation of the R&D tax credit as of June 30, 2025.

 

R&D costs for materials & supplies relate mainly to manufacturing costs charged by the Company’s main manufacturing vendor, AGC Biologics. There were no significant differences with respect to the previous period.

 

Compensation costs relate to R&D personnel wages, salaries, and share-based compensation, including social contributions, and other related personnel costs. The significant reduction in these costs compared to the same period of the previous year is due to the offsetting effect of the reversal of the 2023 and 2024 bonus provision for unpaid and cancelled bonuses.

 

Travel & entertainment expenses relate mainly to business trips and scientific conferences. Other R&D expenses relate to minor general operating costs.

 

Other R&D costs relate to expenses of various nature that are normally variable and not material.

 

 

The Company’s general and administrative expenses are also a combination of third-party and related-party expenses, as detailed below:

 

   Six Months Ended June 30, 2025 
   Third parties   Related parties   Total 
     
Compensation (including share-based)  €337,613   €594,625   €932,238 
Accounting, legal & other professional   363,921    10,070    373,991 
Communication & IT - related   83,167    -    83,167 
Facility & insurance - related   2,257    8,689    10,946 
Consultants & others   195,124    7,800    202,924 
Others   323,110    1,981    325,091 
Total  €1,305,192   €623,165   €1,928,357 

 

   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   85,277    -    85,277 
Facility & insurance-related   984    8,120    9,104 
Consultants & others   324,306    -    324,306 
Others   350,752    967    351,719 
Total  €1,770,271   €707,707   €2,477,978 

 

The decrease in compensation expenses compared to the same period of the prior year was mainly due to a former employee’s contractual relationship with the Company ending in the second half of 2024. Furthermore, a portion of the performance bonuses previously accrued in 2023 and 2024 were reversed, generating an offsetting effect on period costs accounted for as a change in accounting estimate.

 

The reduction in accounting, legal & other professional fees was mainly the result of a review of certain agreements with external professionals, which generated savings.

 

Facility & insurance-related costs include expenses for the Company’s office space and parking, which are charged by OSR.

 

Consultants & other third-party costs decreased compared to the same period of the prior year, both due to savings generated from a review of ongoing agreements with external professionals, and a Company advisor’s contractual relationship was terminated.

 

Consultants & others expenses, presented under the related parties column, pertain to additional compensation for the CEO in his new role as the Company’s Chairman, for the months of May and June 2025.

 

Other costs relate to a variety of administrative and general expenses for approximately €51,000, depreciation expenses for approximately €14,000, insurance for approximately €93,000 (specifically the limited liability Director and Officers, or “D&O,” policy), registration fees (Nasdaq, SEC, etc.) for approximately €30,000, membership fees for approximately €12,000, patent maintenance for approximately €131,000 and other various minor expenses as institutional website maintenance, data protection compliance, car leasing and car maintenance, conventions and meetings, etc.

 

 

Others related parties expenses primarily pertain to a new insurance policy for the CEO in his position as executive employee (General Manager) of the Company.

 

 

The Company’s accounts payable to related parties comprise the following:

 

 

   At June 30,   At December 31, 
   2025   2024 
    (Unaudited)      
San Raffaele Hospital (OSR)  €-   €180,116 
Total  €-   €180,116 

 

The Company’s accrued expenses to related parties comprise the following:

 

   At June 30,   At December 31, 
   2025   2024 
    (Unaudited)      
San Raffaele Hospital (OSR)  €198,163   €128,188 
Pierluigi Paracchi   -    336,000 
Richard Slansky   7,491    243,101 
Carlo Russo   9,988    324,055 
Studio Legale Lexia   10,070    - 
Bernhard Gentner   5,000    - 
Total  €230,712   €1,031,345 

 

The decrease in accrued expenses to related parties compared to the prior period is attributable to the reversal of performance bonus accruals related to 2023 and 2024 for partial payment or cancellation.

 

The Company has identified the following related parties:

 

  ● Pierluigi Paracchi (director, CEO, 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 the Scientific Advisory Board);
     
  ● Carlo Russo (Chief Medical Officer and Head of Development);
     
  ● Richard Slansky (Chief Financial Officer);
     
  ●

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).

 

  ●

Studio Legale Lexia (appointed June 2025 as legal services provider to the Company). Giacomoantonio Paracchi , brother of the Company CEO, is a partner of Lexia.

 

 

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, and co-founder. His new executive employment agreement with the Company, effective April 1, 2025, provides an annual gross salary of €451,560 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.

 

Effective from May 2025, Mr. Paracchi also receives an annual compensation of €45,000 for his role as the Company’s Chairman of the Board of Directors.

 

In June 2025, previously accrued performance bonuses for the years 2023 (€168,000) and 2024 (€168,000) were paid, for a total gross amount of €336,000. No bonuses were accrued for the six months ended June 30, 2025.

 

In June 2025, Mr. Paracchi received NSOs on 80,000 of the Company’s ADSs, compared to July 2024, when he received options on 120,000 of the Company’s ADSs.

 

For the six months ended June 30, 2025, and June 30, 2024, the Company expensed approximately €307,000 (€364,000 including social contribution and TFR) and €300,000 (€357,000 including social contribution and TFR), respectively, 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 SAB - Scientific Advisory Board, 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 of Directors whereby he and his staff perform pre-clinical studies for the Company. The latest consulting agreement with Dr. Naldini was signed on June 20, 2022, which included an annual fee of €100,000 starting July 1, 2022.

 

On May 12, 2025, the consulting agreement dated June 20, 2022, was amended to extend its validity for an additional 12 months, from July 1, 2025, to June 30, 2026. The contract will not be automatically renewed beyond this period. Additionally, the annual fee for the extended term was reduced to €50,000.

 

As of June 30, 2025, and June 30, 2024, Dr. Naldini billed €50,000, 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. In addition, he analyzes clinical biological data. The consulting agreement with Dr. Gentner started on July 1, 2022, and provides fees in the amount of €22,500 per year.

 

On May 8, 2025, the consulting agreement originally dated April 1, 2016, and subsequently amended on July 1, 2022, was further amended to reduce the annual compensation for Dr. Gentner from €45,000 to €22,500, effective July 1, 2025. The agreement will remain in effect for a fixed term of one (1) year, from July 1, 2025, through June 30, 2026.

As of June 30, 2025, and June 30, 2024, Dr. Gentner billed €22,500, and all the issued invoices were paid.

 

In February 2024, Dr. Gentner entered into an addendum to the consulting agreement in which the Company agreed 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 stipulated the fees that were to be billed progressively, if and when the expected research steps were met.

 

At June 30, 2024, only the first step was achieved, billed, and paid in the amount of €5,000.

 

 

At June 30, 2025, the second step was achieved, with an accrued (not yet paid) amount of €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, plus a 30% bonus, subject to Board approval.

 

In June 2025, previously accrued performance bonuses for the years 2023 and 2024 were reversed for a total amount of approximately €260,000. No bonuses were accrued for the six months ended June 30, 2025.

 

In June 2025, Mr. Russo received NSOs on 65,000 of the Company’s ADSs, compared to July 2024 when he received NSOs on 100,000 of the Company’s ADSs.

 

For the six months ended June 30, 2025, and June 30, 2024, the Company expensed approximately €226,379, gross of the impact of the bonus reversal, and €329,000, 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.

 

In June 2025, Mr. Slansky was awarded a bonus of approximately €98,832 (gross amount), related to the activity performed in 2023, and €49,416 (gross amount), related to the activity performed in 2024, and accrued in the respective periods.

 

The 2023 bonus was allocated as follows:

 

  - 15,338 fully vested NSOs based on the Black-Scholes pricing model in place of €47,997 cash as a portion of the 2023 bonus;
     
  - €45,902 paid in cash to Mr. Slansky;
     
  - €2,196 and €1,318, respectively, allocated from Mr. Slansky’s bonus to two (2) finance employees and paid in cash.

 

The original 2024 bonus amount accrued was approximately €108,000; however, this was reduced by 50% and allocated as follows:

 

  - 7,669 fully vested NSOs based on the Black-Scholes pricing model in place of €23,998 cash as a portion of the 2024 bonus;
     
  - €18,531 paid in cash to Mr. Slansky;
     
  - €3,089, €1,853, and €1,235, respectively, allocated from Mr. Slansky’s bonus to three (3) finance employees and paid in cash.

 

No bonuses were accrued for the six months ended June 30, 2025.

 

For the six months ended June 30, 2025, and June 30, 2024, the Company expensed approximately €399,673 gross of the impact of the bonus reversal and €243,000, respectively, related to compensation for Mr. Slansky.

 

 

OSR – San Raffaele Hospital

 

San Raffaele Hospital (“OSR”) 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, replacing its prior license arrangement. The ARLA became effective following the required authorization under Italy’s Golden Power regulations (Law Decree No. 21/2012), which was granted by the competent Italian authority on April 20, 2023.

 

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 an additional 12-month period, 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 were 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 United States, the first commercial sale of a licensed product in the United States 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 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). (See Note 18. 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 the enforcement of the patents and know-how rights, at its own expense. If 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 if 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 if 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 outlined 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 sponsored 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, 2025, the cumulative total amount of expenses for the OSR clinical trial activity from inception amounted to approximately €11.8 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, 2025, 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 of 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, 2025, the Company recorded and paid approximately €0.5 million for the CP1 SRA studies.

 

Operating leases

 

The Company entered into a non-cancelable lease agreement for office space in December 2020. (See Note 18. Commitments and contingencies.)

 

 

Studio Legale Lexia

 

On June 4, 2025, the Company entered into an agreement for the provision of legal services with Studio Legale Lexia (“Lexia”). As of June 30, 2025, accrued expenses – related party included €10,070 for legal services provided by Lexia.