BERGEN, Norway , Nov. 13, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharma-ceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced financial results for the quarter and half year ended September 30, 2024, and provided a business update.

Highlights, including post period:

BGBC016 1L NSCLC STK11m Study

• Ph1b enrollment completed; acceptable safety and pharmacokinetics announced in September 2024
• The Ph2a portion of the study continues to accrue patients both in the US and in Europe

1L STK11m NSCLC: a Widely Recognized Risk Factor

• New published data from MD Anderson continues to support the need for improved therapies in this patient population which is poorly served today

Tilvestamab

• After extensive out-reach, the Company has decided to discontinue all tilvestamab activities including out-licensing activities

Martin Olin, Chief Executive Officer of BerGenBio stated: "BerGenBio continues to progress its focused strategy to develop its lead AXL inhibitor bemcentinib in first-line NSCLC patients with mutations in the STK11 gene which, we believe, represent a significant commercial opportunity. The on-going BGBC016 study in this population continues to progress and recently announced Ph1b data supports the safety and adequate pharmacokinetics of bemcentinib in combination with current standard of care therapy. The Ph2a portion of the study continues to accrue patients both in the US and in Europe. We expect to share a first Interim Analysis in the first part of 2025."

Third Quarter 2024 Financial Highlights

• The operating loss for the quarter was NOK 24.8 million (2023: NOK 27.9 million)
• Net cash flow was negative by NOK 27.7 million (2023: NOK 55.4 million)
• Cash and cash equivalents amounted to NOK 174.8 million by the end of September 2024 (NOK 200.1 million by end of June 2024 and NOK 169.3 million by end of September 2023)

Presentation and Financial Report

The Q3 2024 Financial report is attached to this stock exchange announcement and the report and the Q3 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 10:00 am CET. The presentation will webcast live. To participate in the webcast, please use the following link:

https://channel.royalcast.com/landingpage/hegnarmedia/20241113_3/

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.

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