NANOBIOTIX Provides Business Update and Reports Half Year 2024 Financial Results
Nanobiotix (NASDAQ: NBTX) provided a business update and reported half-year 2024 financial results. Key highlights include:
1. Favorable safety profile and tumor response for RT-NBTXR3 followed by anti-PD-1 in head and neck cancer patients.
2. Several clinical milestones expected in the next 12-18 months for pancreatic, head and neck, esophageal, and lung cancers.
3. €66.3 million in cash and cash equivalents as of June 30, 2024, with runway extended into Q4 2025.
4. Revenue increased to €9.3 million, up from €3.3 million in H1 2023.
5. Net loss of €21.9 million, or €0.46 per share, compared to €28.1 million, or €0.80 per share in H1 2023.
6. Ongoing global Phase 3 trial (NANORAY-312) for head and neck cancer with interim analysis expected by 1H2026.
Nanobiotix (NASDAQ: NBTX) ha fornito un aggiornamento aziendale e ha riportato i risultati finanziari del primo semestre 2024. I principali punti salienti includono:
1. Profilo di sicurezza favorevole e risposta tumorale per RT-NBTXR3 seguito da anti-PD-1 nei pazienti affetti da cancro testa-collo.
2. Diversi traguardi clinici attesi nei prossimi 12-18 mesi per i tumori del pancreas, testa-collo, esofago e polmoni.
3. €66,3 milioni in contante e equivalenti alla data del 30 giugno 2024, con un prolungamento della liquidità fino al quarto trimestre del 2025.
4. Fatturato aumentato a €9,3 milioni, rispetto ai €3,3 milioni del primo semestre 2023.
5. Perdita netta di €21,9 milioni, ossia €0,46 per azione, rispetto ai €28,1 milioni, o €0,80 per azione, nel primo semestre 2023.
6. In corso uno studio globale di fase 3 (NANORAY-312) per il cancro testa-collo, con analisi intermedia prevista entro la prima metà del 2026.
Nanobiotix (NASDAQ: NBTX) proporcionó una actualización empresarial e informó sobre los resultados financieros del primer semestre de 2024. Los puntos destacados incluyen:
1. Perfil de seguridad favorable y respuesta tumoral para RT-NBTXR3 seguido de anti-PD-1 en pacientes con cáncer de cabeza y cuello.
2. Se esperan varios hitos clínicos en los próximos 12-18 meses para cánceres de páncreas, cabeza y cuello, esófago y pulmón.
3. €66,3 millones en efectivo y equivalentes a fecha del 30 de junio de 2024, con la liquidez extendida hasta el cuarto trimestre de 2025.
4. Los ingresos aumentaron a €9,3 millones, frente a €3,3 millones en el primer semestre de 2023.
5. Pérdida neta de €21,9 millones, o €0,46 por acción, en comparación con €28,1 millones, o €0,80 por acción en el primer semestre de 2023.
6. En curso un ensayo global de fase 3 (NANORAY-312) para el cáncer de cabeza y cuello, con análisis intermedio previsto para la primera mitad de 2026.
Nanobiotix (NASDAQ: NBTX)는 비즈니스 업데이트를 제공하고 2024년 반기 재무 결과를 보고했습니다. 주요 하이라이트는 다음과 같습니다:
1. 두경부암 환자를 위한 RT-NBTXR3 뒤에 항-PD-1과 함께하는 유리한 안전성 프로파일 및 종양 반응.
2. 췌장암, 두경부암, 식도암 및 폐암에 대한 향후 12-18개월 내 여러 임상 이정표 예상.
3. 2024년 6월 30일 기준 현금 및 현금성 자산은 6,630만 유로로, 2025년 4분기까지의 운영 자금 확보.
4. 매출이 930만 유로로 증가, 2023년 상반기 330만 유로에서 증가.
5. 순손실은 2,190만 유로, 즉 주당 0.46 유로로, 2023년 상반기 2,810만 유로, 주당 0.80 유로에 비해 감소.
6. 두경부암에 대한 글로벌 3상 시험(NANORAY-312) 진행 중, 중간 분석은 2026년 상반기 내에 예상됨.
Nanobiotix (NASDAQ: NBTX) a fourni une mise à jour de l'entreprise et a rapporté les résultats financiers du premier semestre 2024. Les principaux points forts incluent :
1. Profil de sécurité favorable et réponse tumorale pour RT-NBTXR3 suivi par anti-PD-1 chez les patients atteints de cancer de la tête et du cou.
2. Plusieurs jalons cliniques attendus dans les 12 à 18 mois pour les cancers du pancréas, de la tête et du cou, de l'œsophage et du poumon.
3. 66,3 millions d'euros en liquidités et équivalents au 30 juin 2024, avec une période de trésorerie prolongée jusqu'au quatrième trimestre 2025.
4. Chiffre d'affaires en hausse à 9,3 millions d'euros, contre 3,3 millions d'euros au premier semestre 2023.
5. Perte nette de 21,9 millions d'euros, soit 0,46 € par action, comparativement à 28,1 millions d'euros, soit 0,80 € par action au premier semestre 2023.
6. Essai mondial de phase 3 en cours (NANORAY-312) pour le cancer de la tête et du cou, avec une analyse intermédiaire attendue d'ici la première moitié de 2026.
Nanobiotix (NASDAQ: NBTX) hat ein Unternehmensupdate bereitgestellt und die Finanzergebnisse für das erste Halbjahr 2024 veröffentlicht. Die wichtigsten Highlights sind:
1. Günstiges Sicherheitsprofil und Tumorreaktion für RT-NBTXR3 in Verbindung mit anti-PD-1 bei Patienten mit Kopf-Hals-Krebs.
2. Mehrere klinische Meilensteine werden in den nächsten 12-18 Monaten für Bauchspeicheldrüsen-, Kopf-Hals-, Speiseröhren- und Lungenkrebs erwartet.
3. 66,3 Millionen Euro in bar und Barmitteln zum 30. Juni 2024, mit einer verlängerten Laufzeit bis zum vierten Quartal 2025.
4. Umsatzsteigerung auf 9,3 Millionen Euro, im Vergleich zu 3,3 Millionen Euro im ersten Halbjahr 2023.
5. Nettoberhand von 21,9 Millionen Euro, oder 0,46 Euro pro Aktie, im Vergleich zu 28,1 Millionen Euro, oder 0,80 Euro pro Aktie im ersten Halbjahr 2023.
6. Laufende globale Phase-3-Studie (NANORAY-312) für Kopf-Hals-Krebs, mit einer Zwischenanalyse, die bis zum ersten Halbjahr 2026 erwartet wird.
- Favorable safety profile and tumor response observed in head and neck cancer patients treated with RT-NBTXR3 followed by anti-PD-1
- Cash runway extended into Q4 2025, providing financial stability
- Revenue increased significantly to €9.3 million from €3.3 million in H1 2023
- Net loss per share decreased to €0.46 from €0.80 in H1 2023
- Achieved NANORAY-312 operational milestone, receiving a $20 million payment from Janssen Pharmaceutica NV
- R&D expenses increased to €22.0 million from €17.8 million in H1 2023
- Cash and cash equivalents decreased to €66.3 million from €75.3 million at the end of 2023
Insights
Nanobiotix's financial results show a mixed picture. Revenue increased significantly to
The clinical progress of NBTXR3 is promising. The 48% overall response rate in anti-PD-1 naïve patients and 28% in resistant patients for head and neck cancer is encouraging, especially considering the heavily pre-treated population. The disease control rates of 76% and 68% respectively further support NBTXR3's potential. The median overall survival of 26.2 months in naïve patients is particularly noteworthy. These results suggest NBTXR3 could be a valuable addition to the immunotherapy landscape, potentially addressing the critical issue of resistance to current treatments.
Nanobiotix's partnership with Janssen significantly enhances its market position. The $20 million milestone payment validates the progress and potential of NBTXR3. The expansion into multiple cancer types, including pancreatic, lung and esophageal, broadens the potential market. The company's focus on combining NBTXR3 with immunotherapy aligns with current market trends. However, competition in the oncology space is fierce and Nanobiotix will need to demonstrate clear differentiation and superior efficacy to capture significant market share. The upcoming clinical milestones in the next 12-18 months will be important for assessing NBTXR3's market potential.
- RT-NBTXR3 followed by anti-PD-1 demonstrated favorable safety profile, disease control and tumor response in patients both naïve and resistant to anti-PD-1, suggesting that NBTXR3 may prime the immune system before checkpoint therapy
- Several clinical milestones expected over the next 12-18 months including updated data in pancreatic, and head and neck cancer, and initial data in esophageal and lung cancer
€66.3 million in cash and cash equivalents as of June 30, 2024, with a cash runway extended into Q4 2025
PARIS and CAMBRIDGE, Mass., Sept. 18, 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 announced its half year financial results for the six-month period ended June 30, 2024.
“We continue to make strong progress advancing our nanoparticle-based therapeutic approach with lead candidate NBTXR3, which is part of our global licensing agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company. The agreement is designed to realize significant therapeutic and market opportunities in solid tumor cancers worldwide, starting with lung and head and neck. We also continue to establish additional expansion opportunities across multiple cancer settings as part of our ongoing collaboration with MD Anderson,” said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. “The potential of NBTXR3 to prime immune activity before an anti-PD-1 inhibitor was further reinforced with new data from Study 1100 announced at the Annual Meeting of American Society for Clinical Oncology (ASCO) showing disease control and tumor response in patients with head and neck cancer that are naïve or resistant to prior anti-PD-1 therapy. We expect several clinical milestones over the next 12-18 months that, would further advance and broaden the potential patient population for NBTXR3 including updated data in pancreatic and head and neck cancer, and initial data in esophageal and lung cancer.”
First Half 2024 Operational Highlights, Pipeline Status and Expected Milestones
Strengthened 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.
Achieved a NANORAY-312 operational milestone as part of global exclusive licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company, for the investigational, potential first-in-class radioenhancer NBTXR3 and subsequently received the
Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): Local Control as Single Agent Activated by Radiotherapy (RT)
- NANORAY-312, a pivotal, global, randomized Phase 3 trial evaluating RT-activated NBTXR3 ± cetuximab vs RT ± cetuximab in elderly patients ineligible for cisplatin chemotherapy
- Interim analysis to be reported after both the requisite number of events has occurred and the last patient is recruited, expected by 1H2026
- Ongoing transfer of the sponsorship to Janssen to facilitate preparations for potentially positive trial results and subsequent steps
- Study 102, a successfully completed Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 in patients ineligible for cisplatin chemotherapy or intolerant to cetuximab. Final results showed topline safety and efficacy data supporting robust anti-tumor activity and a well-tolerated profile in elderly patients with a high burden of comorbidity (n=56)
Non-Small Cell Lung Cancer (NSCLC)
- Janssen-led randomized Phase 2 study evaluating NBTXR3 + chemoradiation followed by anti-PD-L1 for patients with inoperable, stage 3 NSCLC
- Study may proceed letter received from the Food and Drug Administration (FDA)
- First patient randomized is the next expected milestone
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC): Priming Immune Response Followed by an Anti-PD-1 Treatment:
- Study 1100, a Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 followed by an anti-PD-1 as a second-or-later line treatment in patients with advanced cancers
- Completed dose escalation part – ongoing dose expansion part. New data in R/M HNSCC Naïve or Resistant to Anti-PD-1 presented at ASCO:
- Favorable safety and feasibility in 68 heavily pre-treated patients with R/M-HNSCC (Intention-to-Treat population; “ITT”)
48% overall response rate (ORR) in evaluable anti-PD-1 naïve patients (n=25);28% ORR in evaluable anti-PD-1 resistant patients (n=25) as per RECIST 1.176% disease control rate (DCR) in evaluable naïve patients;68% DCR in evaluable resistant patients as per RECIST 1.1- Preliminary review of survival data in ITT anti-PD-1 naïve patients (n=33) showed mPFS of 7.3 months and mOS of 26.2 months
- ITT anti-PD-1 resistant patients (n=35) showed mPFS of 4.2 months and mOS of 7.8 months
- Completed dose escalation part – ongoing dose expansion part. New data in R/M HNSCC Naïve or Resistant to Anti-PD-1 presented at ASCO:
- Initial data from immunotherapy resistant patients with multiple primary tumors expected in 2025
- Data supports further evaluation in randomized clinical trials which may include a potential registrational pathway for NBTXR3 in combination with an immunotherapy.
Pancreatic, Lung and Others: Expanding NBTXR3 Opportunity Through a Strategic Collaboration with The University of Texas MD Anderson Cancer Center to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profiles
Five ongoing clinical trials in advanced solid tumors:
- Advanced Solid Tumors with Lung or Liver Metastases: Phase 1/2 study (NCT05039632) of RT-activated NBTXR3 plus an anti-PD-1/L-1 immune checkpoint inhibitor
- Recurrent or Metastatic Head and Neck Cancer: Phase 2 study (NCT04862455) of RT-activated NBTXR3 in combination with anti-PD-1
- Inoperable Non-Small Cell Lung Cancer (NSCLC): Phase 1 study (NCT04505267) of single agent RT-activated NBTXR3
- Dose escalation completed and dose expansion ongoing. Established RP2D after determination of injection feasibility and observation of a favorable safety profile.
- Esophageal Cancer: Phase 1 study (NCT04615013) of RT-activated NBTXR3 in combination with chemotherapy
- Pancreatic Cancer: Phase 1b study (NCT04484909) of RT-activated NBTXR3 after cytotoxic chemotherapy for patients with locally advanced pancreatic cancer (LAPC)
Multiple expected clinical milestones:
- Updated Phase 1b dose escalation data in pancreatic cancer expected 2H2024
- Initial Phase 1 dose escalation data in inoperable, recurrent NSCLC amenable to re-irradiation expected 1H2025
- Completion of dose escalation in Phase 1b/2 trial in esophageal cancer expected in 2024, initiation of dose expansion part, and presentation of first data in 2025
Half Year 2024 Financial Results
Revenue and Other Income: Revenue and other income has increased for the six months ended June 30, 2024, to
Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical and manufacturing expenses related to the development of NBTXR3. These expenses for the six months ended June 30, 2024, were
Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. Total SG&A expenses for the six months ended June 30, 2024, were
Net loss: Net loss attributable to common shareholders for the six months ended June 30, 2024, was
Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2024, were
Based on the current operating plan and financial projections, we anticipate that the cash and cash equivalents of
Availability of the Half Year 2024 Financial Reports
The 2024 half-year financial report has been filed with the French financial market authority (Autorité des marchés financiers). It is available to the public on the Company’s website, www.nanobiotix.com.
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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FAQ
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