GNTA News & Events

Genenta Science intends to target majority ownership in companies with established operating profitability, typically generating up to approximately EUR 5M in EBITDA. In this context, Genenta plans to adopt the new corporate name of Saentra Forge with a new Nasdaq ticker symbol of (SAEN). Saentra Forge intends to pursue a strategy by acquiring targets at private-market valuations and integrating these companies under Saentra Forge. Through this integration, the company will seek to enhance these businesses through operational upgrades, institutional-grade governance, and improved financial visibility. Execution has commenced with ATC, a defense-sector company. Genenta has entered into a binding agreement according to which it will provide funding for ATC through a series of reserved capital increases, via a performance-based and staged acquisition to support operations with the ultimate goal of owning a controlling position in ATC upon the achievement of defined performance milestones. The transaction has received the required clearance under the Golden Power regulatory framework. ATC holds UAMA and SeRNI export-control licenses, NATO qualifications, and authorization from the Italian Ministry of Defense, and its platforms are used by special-forces units and include combat-proven systems. Genenta expects to fund a total of EUR 5.1M in several performance-driven tranches. ATC is projecting revenues of approximately EUR 4M in 2026, increasing to around EUR 9M by 2027. The company operates with a solid net cash position and no outstanding bank debt, reflecting a disciplined management structure. On the profitability side, ATC forecasts EBITDA of more than EUR 2M in 2026, with management expecting EBITDA to approximately double in 2027. In addition, ATC anticipates closing 2026 with a cash balance exceeding EUR 2M, and expects to further strengthen its liquidity position by ending 2027 with cash exceeding EUR 5M. At the core of the company's strategic configuration is the Praexidia Foundation, which has become a shareholder. The Praexidia Foundation is a private law foundation bringing together figures from Italian government institutions, the defense industry, and the armed forces. The company, the foundation, and Pierluigi Paracchi, founder and CEO, have entered into a shareholders' agreement that provides for consultation rights on corporate transactions and a renewable five-year lock-up. The company expects its cash, cash equivalents, and marketable securities at December 31, 2025, to be approximately $33M, compared to $17.7M at June 30, 2025. The increase is primarily due to the company's registered direct offering with certain institutional investors.

Genenta Science announced an update from its ongoing TEM-GBM study in newly diagnosed glioblastoma multiforme patients with an unmethylated MGMT gene promoter. As of the November 21, data cut, 25 patients have been treated with Temferon. These data are compared to the previously disclosed April 15 cut, communicated on July 1. More than seven months after the prior update, key survival metrics for the TEM-GBM patients remain consistent. In total, 44% of patients have reached 18-month survival, compared to 38% reported in April. Two-year survival rate continues to be 29% and median overall survival remains at 17 months, both consistent with prior findings. For context, historical cohorts of uMGMT patients treated with standard of care typically show a two-year survival rate of approximately 14% and median overall survival of 13-15 months. The study includes the first patient who has reached three years of survival following Temferon administration. During this period, the patient did not receive additional therapeutic interventions or second-line treatments. At the follow-up visit conducted at three years, imaging indicated disease progression and the patient subsequently underwent a second surgery. The patient has continued on protocol-scheduled assessments and has recently completed the 3.5-year follow-up visit within the long-term surveillance study. This patient is also the second in the study who has not required further therapeutic interventions during the reported follow-up, a period that overlaps with the window in which recurrence is commonly observed in GBM. These observations are descriptive only, occur within a disease setting known for heterogeneous clinical courses, and individual patient outcomes may vary. As the first clinical setting in which the platform is being evaluated, the GBM study also provides early immune observations on Temferon's behavior within the tumor microenvironment. These preliminary findings include indications that bone-marrow-derived myeloid cells can reach the tumor site and deliver immunotherapeutic payloads in situ, in a manner that is consistent with the intended design of the platform. While exploratory in nature and subject to further confirmation in larger controlled studies, these observations are helping to inform the broader development of Temferon - including potential combination approaches - and the evolution of the underlying cell-based delivery technology.

Genenta Science and Anemocyte announced a strategic collaboration with a focus on off-the-shelf lentiviral vector Plasmid DNA technology platform. This new agreement builds and expands on the existing partnership between the two companies, which has focused on the production of Plasmid DNA. The partnership leverages Genenta's LVV Plasmid DNA technology.

Genenta Science announced that a total of 38 patients were enrolled in newly diagnosed glioblastoma multiforme study, with 25 patients receiving Temferon. Two patients have been enrolled in the TEM-LT long-term follow-up study, surviving three years from the time of 1st surgery. One of these long-term survivors has not experienced disease progression following Temferon administration and has not required any second-line therapies. The other showed initial signs of disease progression that subsequently stabilized without additional therapeutic intervention. Both these cases suggest possible Temferon-mediated control of disease progression, which warrants further investigation in larger studies. As of the April data cutoff, the survival rate at two years in the GBM trial for unmethylated MGMT patients remained consistent at 29% with median overall survival holding steady at 17 months. In historical cohorts, uMGMT patients receiving standard of care have shown a two-year survival rate of approximately 14% and a median overall survival of 13 to 15 months. In parallel, the TEM-GU Phase 1 study-designed to enroll 12 patients with genitourinary tumors-has begun recruitment. In this trial, Temferon is administered at a fixed dose of 4M genetically modified cells per kilogram of body weight-a level previously shown to be safe and well tolerated in the TEM-GBM dose-ranging study. Genenta aims to demonstrate the safety and tolerability of Temferon in patients with Metastatic Renal Cell Carcinoma by year-end. The study is designed to evaluate Temferon in combination with immune checkpoint inhibitors or tyrosine kinase inhibitors to assess the potential for immunologic synergy in this patient population. Further clinical updates will be shared once sufficient patient experience has been gained to support meaningful interpretation. Temferon's mechanism of action is based on the reprogramming of the tumor microenvironment, which promotes the activation and durability of adaptive immune responses. A scientific manuscript demonstrating Temferon's potential to enhance and prolong the durability of CAR-T activity in preclinical murine models of solid tumors has been accepted for publication in Science Translational Medicine.