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BerGenBio

Earnings Release Aug 21, 2024

3555_rns_2024-08-21_526d23c4-f016-46f1-9a33-d275d69393e8.html

Earnings Release

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BerGenBio Second Quarter Results 2024: Solid clinical and financial progress

BerGenBio Second Quarter Results 2024: Solid clinical and financial progress

Bergen, Norway, August 21, 2024 - 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/ (https://eur03

.safelinks.protection.outlook.com/?url=https%3A%2F%2Fchannel.royalcast.com%2Fland

ingpage%2Fhegnarmedia%2F20240821_12%2F&data=05%7C02%7Crune.skeie%40bergenbio.com%

7C603f1ebca2ae4f32a07a08dc8937d2fe%7C2b50b422ca6d42af9fc0741b248bb071%7C0%7C0%7C6

38536120117732258%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJ

BTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=2XjWkqqsvMF9Ssauo43YNkyy7gsb2CmUNV

QvyLu2XGU%3D&reserved=0)

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

[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 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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