Bemcentinib

Ph1b data support safety, predictable PK and adequate plasma exposure BERGEN, Norway, Oct. 7, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced today preliminary safety data from the Phase 1b portion of the BGBC016 study in first-line (1L) Non-Small Cell Lung Cancer (NSCLC) patients. The Phase 1b part of the study evaluated three escalating doses of BerGenBio's selective AXL inhibitor bemcentinib in combination with standard chemo-immunotherapy (CIT), doublet chemotherapy and pembrolizumab, Keytruda®, for the 1L treatment of advanced/metastatic NSCLC patients. The primary endpoint was the assessment of the safety profile of the combination in NSCLC patients regardless of their STK11 mutational status. Key conclusions include: All three selected doses demonstrated that the triplet combination is well tolerated with no new safety signals identified, supporting the further clinical development of bemcentinib and CIT in 1L NSCLC patients. No dose-related impact on electrocardiographic changes (QTc), a known class effect of tyrosine kinase inhibitors, was reported for bemcentinib during the observation period. Pharmacokinetic analyses confirmed adequate plasma exposure of bemcentinib, achieving levels consistent with that previously observed in responders in BerGenBio's BGBC008 study of bemcentinib and pembrolizumab in second-line NSCLC patients. Martin Olin, Chief Executive Officer of BerGenBio, commented: "The data show that bemcentinib has a manageable safety profile and gives us increased confidence in continuing the BGBC016 clinical trial. The global trial is currently enrolling patients in Phase 2a targeting patients with a mutation in the STK11 gene, and we look forward to sharing the first preliminary data as they mature." Contacts Martin Olin CEO, BerGenBio ASA [email protected] Rune Skeie, CFO, BerGenBio ASA [email protected] Investor Relations / Media Relations Jan Lilleby [email protected] About STK11m NSCLC Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11. AXL plays a significant role in the survival and spread of cancer and STK11m NSCLC patients have a high expression of AXL suggesting that AXL is an important target to prevent disease progression and resistance to existing therapies. Bemcentinib's selective inhibition of AXL has been shown to improve the response to immune checkpoint inhibition in STK11m patient-derived preclinical models and in early clinical studies. There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients. 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 development for STK11 mutated NSCLC and severe respiratory infections. BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more information, visit This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision SOURCE BerGenBio ASA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BERGEN, Norway, Aug. 21, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced financial results for the quarter and half year ended June 30, 2024, and provided a business update. 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 2 nd 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 of NOK 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 to NOK 120.2 million in first half 2023. Operating expenses NOK 50.8 million in Q2 2024 compared to NOK 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 . 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: A recording of the webcast will be available at in the Investors/Financial Reports section () shortly afterwards. Contacts Martin Olin CEO, BerGenBio ASA [email protected] Rune Skeie, CFO, BerGenBio ASA [email protected] Media Relations Jan Lilleby [email protected] 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 Bergen, Norway, with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more information, visit 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 The following files are available for download: