NANOBIOTIX Provides Third Quarter 2024 Update and Progress on Nanotherapeutics Platforms
Nanobiotix provided its Q3 2024 update, highlighting key operational progress. The company transferred US sponsorship of the global Phase 3 NANORAY-312 head and neck cancer study to Janssen, marking a important step toward potential NBTXR3 regulatory submission. The company reported €53.2 million in cash and cash equivalents as of September 30, 2024, with runway into Q4 2025.
Updates on NBTXR3 in pancreatic cancer and lung cancer studies with MD Anderson are expected in Q4 2024 and 1H 2025, respectively. The company strengthened its Supervisory Board with Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers. An interim analysis for NANORAY-312 is anticipated after reaching required events and last patient recruitment in 1H 2026.
Nanobiotix ha fornito un aggiornamento sul terzo trimestre del 2024, evidenziando i principali progressi operativi. L'azienda ha trasferito il patrocinio statunitense dello studio globale di Fase 3 NANORAY-312 sul cancro testa-collo a Janssen, un passo importante verso la potenziale sottomissione regolatoria di NBTXR3. L'azienda ha riportato €53,2 milioni in contante e liquidità al 30 settembre 2024, con una crescita prevista fino al quarto trimestre del 2025.
Gli aggiornamenti su NBTXR3 negli studi sul cancro pancreatico e sul cancro ai polmoni con il MD Anderson sono attesi nel quarto trimestre del 2024 e nel primo semestre del 2025, rispettivamente. L'azienda ha rafforzato il suo Consiglio di Sorveglianza con la Dott.ssa Margaret A. Liu e la Sig.ra Anat Naschitz come osservatori del consiglio. Un'analisi intermedia per NANORAY-312 è attesa dopo il raggiungimento degli eventi richiesti e l'arruolamento dell'ultimo paziente nel primo semestre del 2026.
Nanobiotix proporcionó su actualización del tercer trimestre de 2024, destacando los avances operativos clave. La empresa transfirió el patrocinio estadounidense del estudio global de Fase 3 NANORAY-312 sobre el cáncer de cabeza y cuello a Janssen, lo que marca un paso importante hacia la posible presentación regulatoria de NBTXR3. La compañía reportó €53.2 millones en efectivo y equivalentes de efectivo al 30 de septiembre de 2024, con recursos para el cuarto trimestre de 2025.
Se esperan actualizaciones sobre NBTXR3 en estudios de cáncer de páncreas y cáncer de pulmón con MD Anderson en el cuarto trimestre de 2024 y en la primera mitad de 2025, respectivamente. La empresa fortaleció su Junta de Supervisión con la Dra. Margaret A. Liu y la Sra. Anat Naschitz como observadoras de la junta. Se anticipa un análisis intermedio para NANORAY-312 después de alcanzar los eventos requeridos y el reclutamiento del último paciente en la primera mitad de 2026.
Nanobiotix는 2024년 3분기 업데이트를 제공하며 주요 운영 진전을 강조했습니다. 회사는 글로벌 3상 NANORAY-312 두경부 암 연구의 미국 스폰서십을 얀센(Janssen)으로 이전하여 NBTXR3의 잠재적인 규제 제출을 향한 중요한 단계를 marked했습니다. 2024년 9월 30일 기준으로 회사는 현금 및 현금성 자산으로 €53.2 백만을 보고했으며, 2025년 4분기까지 운영 자금을 확보했습니다.
MD 앤더슨과 함께하는 췌장암 및 폐암 연구에 대한 NBTXR3의 업데이트는 2024년 4분기 및 2025년 상반기에 각각 예상됩니다. 회사는 이사회 관찰자로 마가렛 A. 리우 박사와 아낫 나쉬츠 양을 임명하여 감독 이사회를 강화했습니다. NANORAY-312에 대한 중간 분석은 요구된 사건과 마지막 환자 모집을 완료한 후 2026년 상반기에 예상됩니다.
Nanobiotix a fourni sa mise à jour pour le troisième trimestre 2024, soulignant les progrès opérationnels clés. La société a transféré le parrainage américain de l'étude mondiale de Phase 3 NANORAY-312 sur le cancer de la tête et du cou à Janssen, marquant une étape importante vers une éventuelle soumission réglementaire de NBTXR3. La société a rapporté 53,2 millions d'euros en liquidités et équivalents de liquidités au 30 septembre 2024, avec des fonds disponibles jusqu'au quatrième trimestre 2025.
Des mises à jour sur NBTXR3 dans les études sur le cancer du pancréas et le cancer du poumon avec le MD Anderson sont attendues au quatrième trimestre 2024 et au premier semestre 2025, respectivement. L'entreprise a renforcé son Conseil de Surveillance avec le Dr Margaret A. Liu et Mme Anat Naschitz en tant qu'observateurs du conseil. Une analyse intermédiaire pour NANORAY-312 est prévue après l'atteinte des événements requis et le recrutement du dernier patient au premier semestre 2026.
Nanobiotix hat sein Update für das 3. Quartal 2024 bereitgestellt und dabei wichtige betriebliche Fortschritte hervorgehoben. Das Unternehmen hat die US-Patenschaft für die globale Phase-3-Studie NANORAY-312 zur Krebsbehandlung im Kopf-Hals-Bereich an Janssen übertragen, was einen wichtigen Schritt in Richtung einer möglichen regulatorischen Einreichung für NBTXR3 darstellt. Zum 30. September 2024 berichtete das Unternehmen über 53,2 Millionen Euro an liquiden Mitteln, was einen gewissen finanziellen Spielraum bis ins 4. Quartal 2025 bedeutet.
Updates zu NBTXR3 in den Studien zu Bauchspeicheldrüsenkrebs und Lungenkrebs mit MD Anderson werden im 4. Quartal 2024 sowie in der ersten Hälfte des Jahres 2025 erwartet. Das Unternehmen hat seinen Aufsichtsrat mit Dr. Margaret A. Liu und Frau Anat Naschitz als Beobachter verstärkt. Eine Zwischenanalyse für NANORAY-312 wird nach Erreichen der erforderlichen Ereignisse und der letzten Patientenrekrutierung in der ersten Hälfte des Jahres 2026 erwartet.
- Successful transfer of US sponsorship for Phase 3 NANORAY-312 study to Janssen
- Strong cash position of €53.2 million as of September 30, 2024
- Cash runway extended into Q4 2025
- Several quarters needed to complete global sponsorship transfer process
- Interim analysis for NANORAY-312 not expected until 1H 2026
Insights
The Q3 update reveals a solid financial position with
The company's pipeline progress, particularly in pancreatic cancer and NSCLC studies with MD Anderson, suggests multiple value-creation opportunities ahead. The upcoming milestones in Q4 2024 and 2025, including data readouts across various cancer indications, could serve as significant catalysts. The addition of industry veterans to the Supervisory Board strengthens governance and strategic oversight.
The advancement of NBTXR3's development program across multiple solid tumor indications demonstrates promising therapeutic potential. The global Phase 3 NANORAY-312 study in head and neck cancer represents the most advanced program, with Janssen's increased involvement signaling confidence in the technology. The expansion into pancreatic cancer, NSCLC and esophageal cancer through the MD Anderson collaboration provides multiple shots on goal.
The Curadigm nanoprimer platform adds another dimension to the company's technology portfolio, potentially offering broader applications in drug delivery. The planned Q4 2024 update could reveal new opportunities in the rapidly evolving nanomedicine field.
- Transferred US sponsorship of global Phase 3 NANORAY-312 head and neck cancer study, a key step in the preparation for potential NBTXR3 regulatory submission
- Added expert industry leaders to Supervisory Board, further strengthening support for the Company’s long-term growth strategy
- NBTXR3 program update from pancreatic cancer study and lung cancer study with MD Anderson expected 4Q 2024 and 1H 2025, respectively
- Update on expansion of product portfolio to include disruptive nanotherapeutic platform Curadigm expected 4Q 2024
€53.2 million in cash and cash equivalents as of September 30, 2024 with cash runway into 4Q 2025
PARIS and CAMBRIDGE, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering nanoparticle-based approaches to expand treatment possibilities for patients with cancer and other major diseases, provided an update on operational progress and reported financial results for the third quarter of 2024.
“Our strong momentum continues as we further execute across initiatives designed to advance our potentially first-in-class nanoparticle-based therapeutic platforms for millions of patients worldwide. In the NBTXR3 program, we began sponsorship transfer of our global, pivotal NANORAY-312, which is a key step for the potential regulatory submission of NBTXR3 and the promise of our lead candidate to help address the unmet needs of 12 million patients with solid tumors globally who receive radiotherapy each year,” said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. “We were also pleased to expand our Supervisory Board to include leading experts in both the scientific and financial communities to help foster sustainable long-term growth across our platforms. In the fourth quarter, we expect updated dose escalation data for NBTXR3 in pancreatic cancer from our MD Anderson collaboration, as well as an update to our Curadigm program, which is the next-wave of nanoparticle-based platforms from Nanobiotix.”
Third Quarter 2024 Operational Highlights
In an important step forward for the potential NBTXR3 regulatory pathway, Nanobiotix and Janssen Pharmaceutica NV, a Johnson & Johnson Company (“Janssen”), have initiated the planned sponsorship transfer of NANORAY-312, a global Phase 3 study evaluating radiotherapy-activated NBTXR3 for patients with head and neck cancer ineligible for cisplatin, from Nanobiotix to Janssen. Nanobiotix has transferred the sponsorship of the study in the United States to Janssen as planned. The process of transferring the remaining global regions is ongoing. Nanobiotix estimates this process will require several quarters to complete. Janssen is the global licensee for NBTXR3 co-development and commercialization. Accountability for the NANORAY-312 sponsorship will enable the licensee to submit NBTXR3 for global registration in the event of positive trial results.
The Company strengthened its Supervisory Board with the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers, two key additions intended to further equip the Company for sustainable long-term growth. Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy, and Ms. Naschitz brings world-class expertise in raising and deploying capital to support disruptive innovation for the benefit of patients, healthcare professionals and investors.
Upcoming Milestones
Janssen License Agreement
- Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): Nanobiotix continues to expect the interim analysis for NANORAY-312 after the required number of events and last patient recruited in 1H 2026
MD Anderson Collaboration
- Pancreatic Cancer: Updated Phase 1b dose escalation data expected 4Q 2024
- NSCLC: Initial Phase 1 dose escalation data in inoperable, recurrent NSCLC amenable to re-irradiation expected 1H 2025
- Esophageal Cancer: Presentation of first Phase 1b/2 data expected in 2025
Preclinical Nanoparticle-Based Platforms
- Curadigm Nanoprimer: Program update on the disruptive potential of Curadigm and the platform’s opportunity to redefine the discovery and design of next-gen therapies expected 4Q 2024
Third Quarter Financial Updates
Nanobiotix reported cash and cash equivalents of
Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of
About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.
Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.
Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV.
About NANOBIOTIX
Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.
Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations.
Nanobiotix is the owner of more than 25 patent families associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system.
For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter
Disclaimer
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 24, 2024 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2023 universal registration document filed with the AMF on April 24, 2024, in Nanobiotix’ 2024 semi-annual report under the caption “Supplemental Risk Factor” filed with the SEC on Form 6-K and with AMF on September 18 2024, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly.
Contacts
| Nanobiotix | |
Communications Department Brandon Owens VP, Communications +1 (617) 852-4835 contact@nanobiotix.com | Investor Relations Department Craig West SVP, Investor Relations +1 (617) 583-0211 investors@nanobiotix.com |
| Media Relations | |
FR – Ulysse Communication Laurent Wormser + 33 (0)6 13 12 04 04 lwormser@ulysse-communication.com | Global – LifeSci Advisors Kevin Gardner +1 (617) 283-2856 kgardner@lifesciadvisors.com |
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