BerGenBio Q2 2024 Results: Strong Clinical and Financial Progress

BerGenBio ASA, headquartered in BERGEN, Norway, is a clinical-stage biopharmaceutical company specializing in the development of innovative AXL kinase inhibitors to address severe unmet medical needs. On August 21, 2024, the company announced its financial results for the quarter and half-year ending June 30, 2024, alongside providing key business updates.

During this period, BerGenBio made significant strides in the BGBC016 clinical trial. This study, focused on first-line non-small cell lung cancer (NSCLC) patients with STK11 mutations, is progressing as planned. The enrollment phase for the Phase 1b portion of the study has been completed, and a Data Safety Monitoring Board review confirmed the safety and tolerability of combining bemcentinib with standard chemo-immunotherapy treatments. This approval has enabled the initiation of the second dose phase in the Phase 2a part of the study, with all clinical sites now activated.

Furthermore, BerGenBio has pioneered a collaboration with Tempus AI, a leading provider of genomic artificial intelligence. This partnership aims to enhance the development of bemcentinib by utilizing comparative clinical data from patients with STK11-mutated NSCLC. The collaboration is expected to provide valuable insights that will support the evaluation of the BGBC016 study outcomes.

Financially, BerGenBio has bolstered its position significantly. The company secured gross funding of NOK 138.9 million from warrant exercises in June 2024, ensuring financial stability until the second half of 2025. At the end of the second quarter of 2024, the company reported a financial position of NOK 200.1 million.

Operating expenses have been stabilized, showing a continued decrease. For the first half of 2024, operating expenses were reported at NOK 90.5 million, a reduction from NOK 120.2 million in the same period of the previous year. During the second quarter of 2024, operating expenses stood at NOK 50.8 million, compared to NOK 47.8 million in the second quarter of 2023.

BerGenBio's CEO, Martin Olin, expressed his satisfaction with the progress of the BGBC016 trial, noting the positive safety review and commencement of the Phase 2a part of the study. He emphasized the company's commitment to sharing preliminary efficacy data as it becomes available and highlighted the strengthened financial position, which, along with disciplined cost management, will sustain planned activities through to the second half of 2025. Olin reiterated that the BGBC016 clinical trial remains the company's top priority, with a focus on uncovering the significant potential value in bemcentinib.

BerGenBio is a biopharmaceutical innovator dedicated to developing drugs that target AXL, positioning it as a crucial element in treating aggressive diseases such as cancer and severe respiratory infections. The company's lead candidate, bemcentinib, is a selective AXL inhibitor currently undergoing clinical trials for STK11-mutated NSCLC and is in preclinical development for severe respiratory infections. BerGenBio operates from its base in Bergen, Norway, with a subsidiary in Oxford, UK, and is listed on the Oslo Stock Exchange under the ticker BGBIO.