Genenta Reports Long-Term Survival Trends and Immune Findings in Brain Tumor (GBM) Trial

Rhea-AI Summary

Genenta Science (Nasdaq: GNTA) reported a November 21, 2025 data cut from its TEM-GBM study in newly diagnosed glioblastoma patients with unmethylated MGMT. As of the cut, 25 patients treated with Temferon showed 44% 18‑month survival (vs 38% in April), a 2‑year survival of 29%, and median overall survival of 17 months, all consistent with prior updates. Historical uMGMT benchmarks cited: ~14% two‑year survival and 13–15 months median OS. One patient reached 39 months post‑surgery without intervening therapy and completed a 3.5‑year follow‑up. Findings include preliminary immune evidence that bone‑marrow‑derived myeloid cells can reach tumor tissue to deliver payloads. The company held approximately $30 million in cash and short‑term investments as of November 1, 2025.

Positive

• 25 patients treated with Temferon (Nov 21, 2025 cut)
• 44% reached 18‑month survival (up from 38%)
• 2‑year survival 29% vs historical ~14%
• Median OS 17 months (consistent with prior update)
• One patient reached 39 months without additional therapy
• Approximately $30M cash and short‑term investments

Negative

• Study observations are descriptive only and exploratory
• Small sample size: 25 patients limits statistical certainty
• Findings require confirmation in larger controlled studies
• Reported individual outcomes may vary due to disease heterogeneity

Insights

Clinical trial and translational oncology expert

Temferon shows encouraging longer-term survival signals and preliminary tumor immune engagement; cash runway noted.

Genenta reports that in 25 TEM-GBM patients with unmethylated MGMT, key survival metrics remain stable: median overall survival of 17 months and a two-year survival rate of 29%, with 44% of patients alive at 18 months; these figures compare to the historical uMGMT two-year rate of ~14% and median survival of 13–15 months, implying a measurable difference on the disclosed metrics.

Mechanistically, early immune readouts suggest bone‑marrow‑derived myeloid cells reach the tumor and deliver payloads in situ, which aligns with the platform's design but remains exploratory. The report appropriately frames individual long-term survivors as descriptive observations in a heterogeneous disease, limiting definitive efficacy claims until controlled data confirm benefit.

Key dependencies and risks include the small cohort size (25) and absence of a randomized control in the disclosed dataset; these limit statistical confidence and leave open alternative explanations for survival differences. Watch for prespecified controlled trial endpoints, a larger patient cohort, and formal statistical analyses over the next 6–24 months. Also note the company holds approximately 30 million in cash and short-term investments as of November 1, 2025, which influences near-term development capacity but does not confirm runway length.

Company Announces Approximately $30 Million in Cash and Short-Term Investments Following Its October 27th Registered Direct Offering

MILAN, Italy and NEW YORK, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a clinical-stage biotechnology company developing a cell-based platform for targeted delivery of therapeutic payloads in oncology, today announced an update from its ongoing TEM-GBM study in newly diagnosed glioblastoma multiforme (GBM) patients with an unmethylated MGMT (uMGMT) gene promoter. As of the November 21, 2025 data cut, 25 patients have been treated with Temferon. These data¹ are compared to the previously disclosed April 15, 2025 cut, communicated on July 1, 2025.

More than seven months after the prior update, key survival metrics for the TEM-GBM patients remain consistent.

• 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 (39 months from initial surgery). 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.

Following the closing of the October 27^th registered direct offering, the Company held approximately $30 million in cash and short-term investments as of November 1^st.

About Genenta Science
Genenta Science (Nasdaq: GNTA) is a clinical stage immuno-oncology company developing a proprietary hematopoietic stem cells therapy for the treatment of a variety of solid tumor cancers. Genenta’s first in class product candidate is Temferon™, which is designed to allow the expression of immune-therapeutic payloads within the tumor microenvironment by bone marrow-derived myeloid cells and enable a durable and targeted response. Genenta has completed the Phase 1 trial for newly diagnosed Glioblastoma Multiforme (GBM) patients with an unmethylated MGMT gene promoter, which suggests the potential reprogramming of the tumor microenvironment and inhibition of myeloid-induced tolerance, while allowing the induction of T cell responses, potentially breaking immune tolerance. Genenta has initiated a Phase 1/2a metastatic Renal Cell Carcinoma study that will also include a combination with immune checkpoint inhibitors. Genenta’s treatments are designed as one-time monotherapies, but with the additional potential, when used in combination, to significantly enhance the efficacy of other approved therapeutics.

Forward-Looking Statements
Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the funding provided by the recently acquired Mandatory Convertible Bond, the Phase 1/2a clinical trial for newly diagnosed GBM patients with uMGMT-GBM, its clinical trial for metastatic RCC or any related studies, as well as Genenta’s ability to fund its research and development plans. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Genenta's Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of the date of this announcement, and Genenta undertakes no duty to update such information except as required under applicable law. This press release discusses product candidates that are under preclinical or clinical evaluation and that have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. Until finalized in a clinical study report, clinical trial data presented herein remain subject to adjustment as a result of clinical site audits and other review processes. No representation is made as to the safety or effectiveness of these product candidates or the use for which such product candidates are being studied. Temferon™ is an investigational product candidate for which the effectiveness and safety have not been established. In addition, Temferon™ is not approved for use in any jurisdiction.

Genenta Science Media
Tiziana Pollio, Mobile: +39 348 23 15 143
E-mail: tiziana.pollio@genenta.com

¹ The clinical data included in this release are preliminary and reflect information collected directly from clinical sites. These data have not yet undergone full quality control review or independent verification by the clinical research organization (CRO).

FAQ

What did Genenta (GNTA) report in the November 21, 2025 TEM‑GBM data cut?

Genenta reported 25 patients treated, 44% 18‑month survival, 29% two‑year survival, and median OS 17 months.

How does Temferon two‑year survival in GNTA's TEM‑GBM trial compare to historical uMGMT outcomes?

Temferon two‑year survival is 29% versus historical uMGMT two‑year survival of approximately 14%.

What immune findings did Genenta (GNTA) report for Temferon in GBM?

Preliminary data indicate bone‑marrow‑derived myeloid cells can reach tumor sites and deliver immunotherapeutic payloads in situ.

Does the TEM‑GBM update change Genenta's cash position (GNTA)?

Following an October 27 registered direct offering, Genenta held approximately $30 million in cash and short‑term investments as of November 1, 2025.

Are GNTA's TEM‑GBM results definitive for Temferon approval or commercialization?

No; the company describes the observations as exploratory and says they require confirmation in larger controlled studies.