Genenta Announces €20 million ($21.9M) Financing To Expand Pipeline As Brain Tumor Trial Is Showing Promising Survival Rates
Genenta Science (GNTA) has secured a €20 million ($21.9M) financing through a Mandatory Convertible Bond from ENEA Tech and Biomedical (ETB) to expand its pipeline. The funding will support advancing Temferon in metastatic Renal Cell Cancer (mRCC).
The bond structure includes a first tranche of €7.5M for safety assessment in the mRCC trial, and a second tranche of €12.5M conditional upon achieving safety milestones. The bond matures in March 2028 with a two-year lock-up period, and ETB's equity will be capped at 29% with a maximum conversion price of $17.64 per share.
Recent data from the Phase 1/2a Glioblastoma Multiforme (GBM) uMGMT trial shows promising results with 29% patient survival at two years (up from 25% in October) and 17 months median overall survival, compared to historical data of 14% two-year survival and 13-15 months median survival with standard care.
Genenta Science (GNTA) ha ottenuto un finanziamento di €20 milioni ($21,9M) attraverso un Obbligazione Convertibile Obbligatoria da ENEA Tech e Biomedical (ETB) per espandere il suo pipeline. Il finanziamento supporterà l'avanzamento di Temferon nel trattamento del Cancro Renale Metastatico (mRCC).
La struttura dell'obbligazione include una prima tranche di €7,5M per la valutazione della sicurezza nella sperimentazione mRCC, e una seconda tranche di €12,5M condizionata al raggiungimento di traguardi di sicurezza. L'obbligazione scade a marzo 2028 con un periodo di lock-up di due anni, e il capitale di ETB sarà limitato al 29% con un prezzo massimo di conversione di $17,64 per azione.
Dati recenti dalla sperimentazione di Fase 1/2a sul Glioblastoma Multiforme (GBM) uMGMT mostrano risultati promettenti con 29% di sopravvivenza dei pazienti a due anni (in aumento rispetto al 25% di ottobre) e 17 mesi di sopravvivenza mediana complessiva, rispetto ai dati storici di una sopravvivenza a due anni del 14% e 13-15 mesi di sopravvivenza mediana con le cure standard.
Genenta Science (GNTA) ha conseguido un financiamiento de €20 millones ($21.9M) a través de un Bono Convertible Obligatorio de ENEA Tech y Biomedical (ETB) para expandir su cartera de proyectos. La financiación apoyará el avance de Temferon en el Cáncer Renal Metastásico (mRCC).
La estructura del bono incluye un primer tramo de €7,5M para la evaluación de seguridad en el ensayo mRCC, y un segundo tramo de €12,5M condicionado al logro de hitos de seguridad. El bono vence en marzo de 2028 con un período de bloqueo de dos años, y el capital de ETB estará limitado al 29% con un precio máximo de conversión de $17.64 por acción.
Datos recientes del ensayo de Fase 1/2a sobre Glioblastoma Multiforme (GBM) uMGMT muestran resultados prometedores con 29% de supervivencia de pacientes a dos años (aumentando desde el 25% en octubre) y 17 meses de supervivencia media global, en comparación con datos históricos de 14% de supervivencia a dos años y 13-15 meses de supervivencia media con el tratamiento estándar.
Genenta Science (GNTA)는 ENEA Tech 및 Biomedical (ETB)로부터 €20백만 ($21.9M)의 자금을 확보하여 파이프라인을 확장했습니다. 이 자금은 전이성 신세포암(mRCC)에서 Temferon의 발전을 지원할 것입니다.
채권 구조에는 mRCC 시험에서 안전성 평가를 위한 첫 번째 분할금 €7.5M과 안전성 기준 달성에 따라 조건부로 지급되는 두 번째 분할금 €12.5M이 포함됩니다. 채권은 2028년 3월 만기되며 2년의 잠금 기간이 있으며 ETB의 지분은 29%로 제한되며 최대 전환 가격은 주당 $17.64입니다.
최근의 1/2a 단계 다형성 교모세포종(GBM) uMGMT 시험 데이터는 2년 동안의 환자 생존율이 29%로 (10월의 25%에서 증가) 중간 전체 생존 기간이 17개월이라는 유망한 결과를 보여줍니다. 이는 표준 치료의 2년 생존율 14% 및 중간 생존 기간 13-15개월과 비교됩니다.
Genenta Science (GNTA) a sécurisé un financement de 20 millions d'euros ($21,9M) par le biais d'une Obligation Convertible Obligatoire de ENEA Tech et Biomedical (ETB) pour étendre son pipeline. Ce financement soutiendra l'avancement de Temferon dans le Cancer Rénal Métastatique (mRCC).
La structure de l'obligation comprend une première tranche de 7,5 millions d'euros pour l'évaluation de la sécurité dans l'essai mRCC, et une seconde tranche de 12,5 millions d'euros conditionnée à l'atteinte de jalons de sécurité. L'obligation arrive à échéance en mars 2028 avec une période de blocage de deux ans, et le capital d'ETB sera plafonné à 29% avec un prix de conversion maximum de 17,64 $ par action.
Des données récentes de l'essai de Phase 1/2a sur le Glioblastome Multiforme (GBM) uMGMT montrent des résultats prometteurs avec 29% de survie des patients à deux ans (en hausse par rapport à 25% en octobre) et 17 mois de survie médiane globale, comparé aux données historiques de 14% de survie à deux ans et 13-15 mois de survie médiane avec le traitement standard.
Genenta Science (GNTA) hat eine Finanzierung in Höhe von 20 Millionen € ($21,9M) durch eine Pflichtwandelanleihe von ENEA Tech und Biomedical (ETB) gesichert, um seine Pipeline zu erweitern. Die Finanzierung wird die Weiterentwicklung von Temferon bei metastasierendem Nierenzellkarzinom (mRCC) unterstützen.
Der Anleihestruktur umfasst eine erste Tranche von 7,5 Millionen € für die Sicherheitsbewertung in der mRCC-Studie und eine zweite Tranche von 12,5 Millionen €, die an das Erreichen von Sicherheitsmeilensteinen gebunden ist. Die Anleihe läuft im März 2028 aus und hat eine zweijährige Sperrfrist, während das Eigenkapital von ETB auf 29% begrenzt ist, mit einem maximalen Umwandlungspreis von $17,64 pro Aktie.
Neueste Daten aus der Phase 1/2a Glioblastoma Multiforme (GBM) uMGMT-Studie zeigen vielversprechende Ergebnisse mit 29% Patientenüberlebensrate nach zwei Jahren (von 25% im Oktober gestiegen) und 17 Monaten medianer Gesamtüberlebenszeit, im Vergleich zu historischen Daten von 14% Überlebensrate nach zwei Jahren und 13-15 Monaten medianer Überlebenszeit mit Standardbehandlung.
- Secured €20M ($21.9M) financing without immediate shareholder dilution
- GBM trial shows improved survival rates: 29% at 2 years vs 14% historical
- Median overall survival increased to 17 months vs 13-15 months historical
- Successfully initiated Phase 1/2a trial in metastatic Renal Cell Carcinoma
- Future shareholder dilution when bond converts in 2028
- Second tranche of €12.5M contingent on achieving safety milestones
- ETB will gain up to 29% equity stake upon conversion
Insights
Genenta's €20 million ($21.9M) financing represents a significant capital injection for a company with a
The Phase 1/2a GBM trial data shows clinically meaningful improvement with
ETB's rigorous due diligence before committing capital adds significant credibility to Genenta's technology. The two-tranche financing structure intelligently links additional capital to clinical milestones, providing investors with clear upcoming catalysts. The
The expansion into metastatic Renal Cell Cancer demonstrates platform versatility and creates multiple paths to potential success, substantially derisking the company's clinical program. This financing transforms Genenta from a single-indication biotech into a multi-program company with enhanced partnership potential.
This financing deal's structure offers compelling benefits to Genenta's balance sheet and strategic position. The
The two-tranche approach creates a milestone-based funding mechanism that aligns capital deployment with clinical progress. The first
ETB's involvement brings substantial intangible value beyond capital. As a foundation supervised by the Italian Ministry with
The lock-up period through 2030 demonstrates long-term investor commitment rather than opportunistic financing. For existing shareholders, this transaction establishes a valuation benchmark substantially above current trading levels without immediate dilution pressure. The change-of-control acceleration clause also preserves acquisition potential, providing flexibility for strategic transactions that might emerge as clinical data matures.
MILAN and NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, today announced a
"ETB conducted a deep and thorough scientific and legal due diligence before committing to this investment. We spent several months in negotiations," said Pierluigi Paracchi, CEO of Genenta. "We believe the mandatory convertible bond terms are indicative of the potential long-term value of Genenta's shares. The bond will not result in immediate dilution to Genenta's shareholders, and is expected to provide the necessary capital to achieve key milestones in the Company's new mRCC trial. Conversion to equity is set for March 2028, followed by a two-year lock-up period. Naturally, the process will be accelerated in the event of a change of control of our Company. ETB is a trusted partner with strong financial backing, which will help ensure the financial stability required to advance the validation of the Temferon platform and our ability to pursue strategic collaborations.”
The February data cutoff from the Phase 1/2a Glioblastoma Multiforme (GBM) uMGMT trial shows an increase in the percentage of patients surviving at two years, now reaching
Notably, the Phase 1/2a trial in metastatic Renal Cell Carcinoma has recently begun enrolling patients, further strengthening the Company's clinical pipeline for Temferon.
Prof. Luigi Naldini, Co-founder of Genenta, added: "We are continuing to demonstrate at pre-clinical and clinical levels Temferon’s ability to reprogram the tumor microenvironment, which in turn induces cell-mediated immune responses, as suggested by Genenta's ongoing GBM trial and which will be under testing in the Company's mRCC trial.”
ETB Mandatory Convertible Bond Investment Terms:
- Total Bond:
€20 million ($21.9M ), subscribed by ETB; - Maturity: three years, with mandatory conversion at maturity (March 2028);
- Lock-up: two years following conversion (March 2030);
- Funding Structure:
- First Tranche:
€7.5 million ($8.2M ), which is expected to provide sufficient funding to assess safety in the ongoing Phase 1/2a trial for mRCC. - Second Tranche:
€12.5 million ($13.7M ), conditional upon achieving safety and tolerability in the ongoing Phase 1/2a trial for mRCC, among other conditions.
- First Tranche:
- ETB equity in Genenta will be capped at
29% . - The maximum conversion price is
$17.64 per share based on an Independent Evaluation conducted by ETB’s Advisor on Genenta.
Note: The information provided herein regarding the Mandatory Convertible Bond is a summary and does not purport to be comprehensive. The full terms and conditions of the Mandatory Convertible Bond are set forth in the official subscription agreement by and between Genenta and ETB and relevant bond regulations, which are detailed and govern the issuance of the Mandatory Convertible Bond. Investors are encouraged to refer to the full documentation. The complete documentation with respect to the Mandatory Convertible Bond is available in the Company’s Form 6-K filing with the SEC filed concurrently with this press release and on the Company's website at www.genenta.com.
About Genenta
Genenta (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 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 patients with an unmethylated MGMT gene promoter, which suggests the potential reprogramming of the tumor microenvironment and inhibiting of myeloid induced tolerance, while allowing the induction of T cell responses, potentially breaking immune tolerance. Genenta has initiated in Q4 2024 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 to be provided by the Mandatory Convertible Bond, the completion and timing of Genenta's ongoing 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, 2023 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 Media
Tiziana Pollio, Mobile: +39 348 23 15 143
Email: tiziana.pollio@genenta.com
FAQ
What are the key terms of GNTA's €20 million convertible bond financing?
How has GNTA's Temferon performed in the Phase 1/2a GBM trial?
What is the purpose of GNTA's new €20 million financing?
When will GNTA's convertible bond convert to equity?
