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BerGenBio Second Quarter Results 2024: Solid clinical and financial progress

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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.

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Positive

  • 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

Negative

  • Operating expenses increased to NOK 50.8 million in Q2 2024 from NOK 47.8 million in Q2 2023

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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 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 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 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 Bergen, Norway, with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more information, visit www.bergenbio.com

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

https://news.cision.com/bergenbio-asa/r/bergenbio-second-quarter-results-2024--solid-clinical-and-financial-progress,c4026515

The following files are available for download:

https://mb.cision.com/Public/15728/4026515/a85d82bb3b88312e.pdf

Q2 and half year 2024 Financial report

 

Cision 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?

BerGenBio reported a strengthened financial position with NOK 200.1 million at the end of Q2 2024. They secured gross funding of NOK 138.9 million from warrant exercise in June 2024, extending funding into H2 2025. Operating expenses for Q2 2024 were NOK 50.8 million.

How is BerGenBio's BGBC016 clinical trial progressing?

The BGBC016 1L NSCLC STK11m study is progressing as planned. Enrollment in the Ph1b part is completed, and all Ph2a sites have been activated. The Data Safety Monitoring Board review supports the safety and tolerability of bemcentinib in combination with standard care, allowing initiation of the 2nd dose in the Ph2a part.

What is the significance of BerGenBio's collaboration with Tempus AI (Nasdaq: TEM)?

BerGenBio's collaboration with Tempus AI aims to accelerate the development of bemcentinib. This data and regulatory partnership will provide prospective comparative clinical data from 1L STK11m NSCLC patients, aiding in the evaluation of BGBC016 results and potentially speeding up the drug development process.

What is BerGenBio's main focus in drug development as of Q2 2024?

BerGenBio's main focus is on bemcentinib, a potentially first-in-class selective AXL inhibitor. It is in clinical development for STK11 mutated NSCLC and preclinical development for severe respiratory infections. The BGBC016 clinical trial for bemcentinib is the company's highest priority.