Bergen, Norway, July 29, 2024, - BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced today that the independent Data and Safety Monitoring Board (DSMB) for BerGenBio's Phase 1b/2a BGBC016 study confirmed acceptable safety at the highest dose tested in the Phase 1b. As a result, the DSMB also recommended that under the study protocol, no additional patients will be required for Phase 1b.

The recommendation of the DSMB allows BerGenBio to proceed per study protocol and open the second dose level in the Phase 2a part of the study in NSCLC patients with STK11 mutations. This portion of the study is already open for enrollment and is designed to evaluate the efficacy of the combination of bemcentinib with pembrolizumab (Keytruda®) and doublet chemotherapy.

Cristina Oliva, Chief Medical Officer of BerGenBio commented, "We continue to be reassured by the safety profile of bemcentinib when combined with the standard of care for 1L NSCLC patients.  Opening the second dose level in the Phase 2a portion of the BGBC016 study will allow us to carefully evaluate the dose response to bemcentinib, an important goal to guide the dose optimization for future trials."

Martin Olin, Chief Executive Officer of BerGenBio added, "The BGBC016 clinical trial is our highest priority, and I am happy to see it continues to progress as planned. NSCLC STK11m patients are not currently eligible for targeted therapy and unfortunately face a very poor prognosis. The medical need is significant, and so are the commercial opportunities.

The Phase 2a is assessing the safety and efficacy of two different doses of bemcentinib in the same treatment combination. As previously communicated, the company expects to present an interim analysis in the second half of this year. 

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / Media Relations

Jan Lilleby

jl@lillebyfrisch.no

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, visitwww.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 subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.