BerGenBio Second Quarter Results 2024: Solid clinical and financial progress
BerGenBio ASA (OSE: BGBIO) reported solid clinical and financial progress in its Q2 2024 results. Key highlights include:
1. BGBC016 1L NSCLC STK11m study progressing well, with Ph1b enrollment completed and Ph2a sites activated.
2. Collaboration with Tempus AI (Nasdaq: TEM) to accelerate bemcentinib development using genomic AI.
3. Strengthened financial position with NOK 138.9 million from warrant exercise, funding secured into H2 2025.
4. Stable cash use with decreased operating expenses: NOK 90.5 million for H1 2024 vs NOK 120.2 million in H1 2023.
5. Focus on bemcentinib as a potential first-in-class selective AXL inhibitor for STK11 mutated NSCLC and severe respiratory infections.
BerGenBio ASA (OSE: BGBIO) ha riportato solidi progressi clinici e finanziari nei risultati del secondo trimestre del 2024. I punti salienti includono:
1. Lo studio BGBC016 1L NSCLC STK11m sta proseguendo bene, con il completamento dell'arruolamento della fase 1b e l'attivazione dei siti della fase 2a.
2. Collaborazione con Tempus AI (Nasdaq: TEM) per accelerare lo sviluppo di bemcentinib utilizzando l'AI genomica.
3. Posizione finanziaria rafforzata con 138,9 milioni di NOK derivanti dall'esercizio di warrant, finanziamenti assicurati fino al secondo semestre del 2025.
4. Utilizzo dei contanti stabile con spese operative ridotte: 90,5 milioni di NOK per il primo semestre del 2024 rispetto ai 120,2 milioni di NOK del primo semestre del 2023.
5. Focus su bemcentinib come potenziale inibitore selettivo AXL di prima classe per il NSCLC mutato STK11 e gravi infezioni respiratorie.
BerGenBio ASA (OSE: BGBIO) informó de un sólido progreso clínico y financiero en sus resultados del segundo trimestre de 2024. Los aspectos más destacados incluyen:
1. El estudio BGBC016 1L NSCLC STK11m está avanzando bien, con el reclutamiento de la fase 1b completado y los sitios de la fase 2a activados.
2. Colaboración con Tempus AI (Nasdaq: TEM) para acelerar el desarrollo de bemcentinib utilizando IA genética.
3. Posición financiera fortalecido con 138.9 millones de NOK provenientes del ejercicio de warrants, financiamiento asegurado hasta el segundo semestre de 2025.
4. Uso de efectivo estable con gastos operativos reducidos: 90.5 millones de NOK para el primer semestre de 2024 frente a 120.2 millones de NOK en el primer semestre de 2023.
5. Enfoque en bemcentinib como un potencial inhibidor selectivo de AXL de primera clase para el NSCLC mutado STK11 y severas infecciones respiratorias.
BerGenBio ASA (OSE: BGBIO)는 2024년 2분기 결과에서 강력한 임상 및 재무 진행 상황을 보고했습니다. 주요 내용은 다음과 같습니다:
1. BGBC016 1L NSCLC STK11m 연구가 순조롭게 진행되고 있으며, 1b 단계의 등록이 완료되고 2a 단계의 사이트가 활성화되었습니다.
2. Tempus AI (Nasdaq: TEM)와의 협력을 통해 유전체 AI를 사용하여 bemcentinib 개발을 가속화하고 있습니다.
3. 강화된 재무 상태로부터 138.9 백만 NOK의 자금을 조달하였으며, 2025년 하반기까지의 자금이 확보되었습니다.
4. 안정적인 현금 사용와 함께 운영 비용이 감소했습니다: 2024년 상반기에 90.5 백만 NOK 사용에 비해 2023년 상반기에는 120.2 백만 NOK였습니다.
5. bemcentinib에 집중하고 있으며, STK11 돌연변이 NSCLC 및 심각한 호흡기 감염에 대한 잠재적인 1세대 선택적 AXL 억제제로 보고되고 있습니다.
BerGenBio ASA (OSE: BGBIO) a signalé des progrès cliniques et financiers solides dans ses résultats du deuxième trimestre 2024. Les principaux faits saillants incluent :
1. Etude BGBC016 1L NSCLC STK11m en bonne voie, avec un recrutement de la phase 1b complété et des sites de la phase 2a activés.
2. Collaboration avec Tempus AI (Nasdaq: TEM) pour accélérer le développement de bemcentinib grâce à l'IA génomique.
3. Position financière renforcée avec 138,9 millions de NOK issus de l'exercice de warrants, financement assuré jusqu'au deuxième semestre 2025.
4. Utilisation stable des liquidités avec des dépenses opérationnelles réduites : 90,5 millions de NOK pour le premier semestre 2024 contre 120,2 millions de NOK pour le premier semestre 2023.
5. Accent sur bemcentinib en tant qu'inhibiteur AXL sélectif de première classe potentiel pour le NSCLC muté STK11 et les infections respiratoires graves.
BerGenBio ASA (OSE: BGBIO) berichtete über solide klinische und finanzielle Fortschritte in den Ergebnissen des 2. Quartals 2024. Die wichtigsten Höhepunkte umfassen:
1. Die BGBC016 1L NSCLC STK11m-Studie verläuft gut, die Rekrutierung in Phase 1b wurde abgeschlossen und die Standorte für Phase 2a wurden aktiviert.
2. Zusammenarbeit mit Tempus AI (Nasdaq: TEM), um die Entwicklung von bemcentinib mithilfe von genomischer AI zu beschleunigen.
3. Gestärkte Finanzposition mit 138,9 Millionen NOK aus der Ausübung von Warrants, Finanzierung bis in die zweite Hälfte 2025 gesichert.
4. Stabiler Bargeldverbrauch mit gesenkten Betriebskosten: 90,5 Millionen NOK für das erste Halbjahr 2024 im Vergleich zu 120,2 Millionen NOK im ersten Halbjahr 2023.
5. Fokus auf bemcentinib als potenziellen selektiven AXL-Inhibitor der ersten Klasse für STK11-mutiertes NSCLC und schwere Atemwegsinfektionen.
- Completed enrollment in Ph1b part of BGBC016 1L NSCLC STK11m study
- Initiated 2nd dose in Ph2a part of BGBC016 study
- Secured gross funding of NOK 138.9 million from warrant exercise
- Decreased operating expenses to NOK 90.5 million for H1 2024 from NOK 120.2 million in H1 2023
- Established collaboration with Tempus AI for accelerated bemcentinib development
- Operating expenses increased to NOK 50.8 million in Q2 2024 from NOK 47.8 million in Q2 2023
Insights
BerGenBio's Q2 2024 results demonstrate financial stability and clinical progress. The company's
Operating expenses have stabilized at
The collaboration with Tempus AI could potentially accelerate development and reduce costs in the long run. Overall, BerGenBio's financial position appears solid, supporting its clinical development plans.
BerGenBio's BGBC016 trial for bemcentinib in 1L NSCLC STK11m patients is progressing well. The completion of Ph1b enrollment and positive safety review allowing Ph2a initiation are encouraging milestones. The focus on STK11-mutated NSCLC, a subgroup with poor prognosis and treatment options, is strategically sound.
The collaboration with Tempus AI for comparative clinical data is an innovative approach. This could provide valuable context for interpreting BGBC016 results and potentially streamline the development process. However, it's important to note that while AI-driven approaches are promising, they're still emerging in clinical development.
Investors should anticipate preliminary efficacy data from Ph2a as a key upcoming catalyst. The selective AXL inhibition approach could potentially address an important unmet need in NSCLC treatment.
Highlights, including post period:
- BGBC016 1L NSCLC STK11m study continues to progress as planned. Enrollment in the Ph1b part completed. Data Safety Monitoring Board review of data from the final Ph1b dose cohort supports safety and tolerability of the combination of bemcentinib with standard of care chemo/immunotherapy allowing initiation of the 2nd dose in the Ph2a part. All Ph2a sites have now been activated.
- Innovative approach established with leading genomic AI provider to accelerate development of bemcentinib. Established data and regulatory collaboration with technology company Tempus AI (Nasdaq: TEM) to provide prospective comparative clinical data from 1L STK11m NSCLC patients to aid in the evaluation of BGBC016 results.
- Strengthened financial position. Secured gross funding of
NOK 138.9 million from warrant exercise in June 2024 securing funding into H2 2025. Financial position ofNOK 200.1 million end of Q2 2024. - Stable cash use. Continued decreased and stabilized operating expenses at
NOK 90.5 million for first half 2024 compared toNOK 120.2 million in first half 2023. Operating expensesNOK 50.8 million in Q2 2024 compared toNOK 47.8 million in Q2 2023.
Martin Olin, Chief Executive Officer of BerGenBio stated:
"The BGBC016 clinical trial continued to progress well during the quarter. An independent review of the final cohort in the Ph1b part showed acceptable safety allowing initiation of the 2nd dose in the Ph2a part, and we completed the activation of the Ph2a sites. We now look forward to sharing preliminary efficacy data from the Ph2a portion of the study as they mature. During the quarter we strengthened our financial position which will, combined with our continuing cost discipline, fund our planned activities into the second half of 2025. The BGBC016 clinical trial is our highest priority, and we remain dedicated to unlocking the significant value potential in bemcentinib."
Presentation and Financial Report
The Q2 2024 Financial report is attached to this stock exchange announcement and the report and the Q2 2024 presentation are available at the Company's website https://www.bergenbio.com/investors/financial-reports.
Webcast details
BerGenBio's senior management team will provide a business update today at 9:45 am CET. The presentation will webcast live. To participate in the webcast, please use the following link:
https://channel.royalcast.com/landingpage/hegnarmedia/20240821_12/
A recording of the webcast will be available at www.bergenbio.com in the Investors/Financial Reports section (https://www.bergenbio.com/investors/financial-reports) shortly afterwards.
Contacts
Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
Media Relations
Jan Lilleby
jl@lillebyfrisch.no
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including cancer and severe respiratory infections. The Company is focused on its proprietary lead candidate, bemcentinib, a potentially first-in-class selective AXL inhibitor in clinical development for STK11 mutated NSCLC and preclinical development for severe respiratory infections.
BerGenBio is based in
Forward looking statements
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties, and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements.
This information is considered to be inside information pursuant to the EU Market Abuse Regulation and subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
This information was brought to you by Cision http://news.cision.com
The following files are available for download:
https://mb.cision.com/Public/15728/4026515/a85d82bb3b88312e.pdf | Q2 and half year 2024 Financial report |
View original content:https://www.prnewswire.com/news-releases/bergenbio-second-quarter-results-2024-solid-clinical-and-financial-progress-302227207.html
SOURCE BerGenBio ASA
FAQ
What were BerGenBio's key financial results for Q2 2024?
How is BerGenBio's BGBC016 clinical trial progressing?
What is the significance of BerGenBio's collaboration with Tempus AI (Nasdaq: TEM)?
What is BerGenBio's main focus in drug development as of Q2 2024?
