BerGenBio

Earnings Release • Aug 23, 2022

BerGenBio reports second quarter and half year 2022 financial results and provides business update

BerGenBio reports second quarter and half year 2022 financial results and provides business update

- Commenced bemcentinib Phase 2b trial in hospitalized COVID-19 patients -

- Initiation of Phase 1a/2b STK11 mutated NSCLC trial planned for 2H22 -

- BerGenBio to host conference call and webcast today at 10:00 AM CEST/4:00 AM

EDT -

BERGEN, Norway, August 23, 2022 - 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 second

quarter and half year ended June 30, 2022 and provided a business update.

"The prioritization of bemcentinib development in two key areas in the second

quarter has created momentum entering the second half of the year," said Martin

Olin, Chief Executive Officer of BerGenBio. "By following strong scientific

rationale, clinical and preclinical data, and areas of significant unmet medical

need, we are confidently enthusiastic about bemcentinib's potential in aiding

patients in two indications of focus: STK11 mutated Non-Small Cell Lung Cancer

and patients hospitalized by COVID-19. The initiation of the next phase of

clinical development for both indications in 2H22 moves us a meaningful step

closer to addressing two large patient populations that are in need of better

treatments."

Clinical Development

Bemcentinib

BerGenBio's lead compound, bemcentinib, is a potent, first-in-class, oral, small

molecule, highly selective inhibitor of the receptor tyrosine kinase AXL, which

is overexpressed in response to cellular stress, inflammation, hypoxia and

chemotherapy. Bemcentinib inhibits the host cells' ability to propagate the

progression of serious disease through the modulation of resistance mechanisms

and the adaptive immune system.

The Company is advancing bemcentinib development in two lung indications, STK11

mutated (STK11m) Non-Small Cell Lung Cancer (NSCLC) and Hospitalized COVID-19

patients, where bemcentinib's novel mechanisms of action and primary

accumulation in the lungs make it uniquely positioned to address severe lung

diseases.

First-Line STK11m NSCLC

BerGenBio is preparing a Phase 1b/2a trial of bemcentinib in 1L STK11m NSCLC, a

group that represents approximately 20% of NSCLC patients. Mutations in the

STK11 gene are highly correlated with poor treatment response and survival with

today's standard of care treatments, including immune checkpoint inhibitors in

NSCLC. Through inhibition of AXL, bemcentinib seeks to prevent AXL activation,

consequently removing the innate immunosuppression that it causes and driving

the proliferation of immune cells to restore sensitivity to immune checkpoint

therapy. UT Southwestern Medical Center in Texas has shown that bemcentinib in

models of NSCLC has the ability to restore the sensitivity of checkpoint

inhibitors. Further bemcentinib is also believed to delay the development of

chemoresistance.

· The detrimental effect of mutations in the STK11 gene on clinical outcomes

was further highlighted by several academic groups at the American Society of

Clinical Oncology (ASCO) meeting in June 2022. In a retrospective study funded

by Roche, Spain (Abstract #9047), of real-world outcomes in 1L NSCLC patients,

STK11m was identified as having the poorest prognosis in all effectiveness

outcomes, including lower response, progression free survival and overall

survival, of 185 detected mutations.

· The Company is preparing and has post period filed an IND with the purpose

to initiate a Phase 1b/2a trial evaluating bemcentinib in combination with a

checkpoint inhibitor and doublet chemotherapy in 1L STK11m NSCLC patients in the

second half of 2022.

· In parallel with the preparation of the Phase 1b/2a trial, the Company is

evaluating the role of STK11 mutations in combination with other relevant co

-mutations such as TP53, KRAS and KEAP1 to further characterize the potential of

bemcentinib is this area of high unmet medical need.

Hospitalized COVID-19 Patients

Bemcentinib is currently being studied in a Phase 2b clinical trial in

hospitalized COVID-19 patients. AXL, when induced by an infection, such as COVID

-19, is known to play a variety of key roles in transporting the virus into

cells, aiding replication, and dampening immune responses. Bemcentinib

selectively inhibits AXL to block viral entry, stimulate the innate immune

system and facilitate tissue repair regardless of known variants or mutations.

· In the ACCORD2 UK platform study of hospitalized COVID-19 patients,

bemcentinib treatment resulted in a clear reduction in clinical deterioration,

causing: a significant reduction in deaths, patients requiring less

supplementary oxygen, a significant reduction in the need for intubation or

ventilation and a shortening of hospital stays compared to the control group.

· Bemcentinib has been selected by an expert group to be studied in a Phase 2b

trial under the EU-SolidAct platform through a sub-protocol enrolling 500

hospitalized COVID-19 patients across Europe.

Mipasetamab Uzoptirine

Post period, ADC Therapeutics announced that the first patient was dosed in a

Phase 1 clinical trial evaluating mipasetamab uzoptirine as a single agent and

in combination with gemcitabine in patients with selected advanced solid tumors.

Mipasetamab uzoptirine contains an AXL-targeting humanized monoclonal antibody

licensed from BerGenBio.

Corporate Activities

BerGenBio strengthened its leadership team in April 2022 with the addition of

Cristina Oliva, M.D., as Chief Medical Officer. Dr. Oliva is a Board-certified

oncologist with over 20 years of senior clinical development experience across

large pharmaceutical, biotechnology and CROs, including her most recent position

as Vice President, Oncology and Head of Oncology Centre of Excellence at IQVIA,

Ltd.

Second Quarter 2022 Financial Highlights

(Figures in brackets = same period 2021 unless otherwise stated)

?      Revenue amounted to NOK 0.0 million (NOK 0.0 million) for the second

quarter 2022

?      Total operating expenses for the second quarter were NOK 88.2 million

(NOK 92.3 million)

?      The operating loss for the second quarter came to NOK 88.2 million (NOK

92.3 million)

?      Cash and cash equivalents amounted to NOK 292.1 million (NOK 367.8

million at the end of the first quarter 2022).

Presentation and Webcast Details

The live webcast link is available at www.bergenbio.com in the

Investors/Financial Reports section. A recording will be available shortly after

the webcast has finished.

Webcast link:

https://channel.royalcast.com/landingpage/hegnarmedia/20220823_9/ (https://eur03.

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

ngpage%2Fhegnarmedia%2F20220823_9%2F&data=05%7C01%7Crune.skeie%40bergenbio.com%7C

3aeb245463454d154b5208da75ee85bb%7C2b50b422ca6d42af9fc0741b248bb071%7C0%7C0%7C637

951964564731223%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBT

iI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=cvdyRoRlYMI2Gew8FkgoPqCwfXPjpUGQ%

2Ba6Xb97EuYg%3D&reserved=0)

Dial-in numbers:

NO: +47-21-956342

UK: +44-203-7696819

US: +1 646-787-0157

SE: +46-4-0682-0620

DK: +45 78768490

Pin: 712491

The first quarter report and presentation are available on the Company's website

in the Investors/Financial Reports section and a recording of the webcast will

be made available shortly after the webcast has finished.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / Media Relations

Graham Morrell

graham.morrell@bergenbio.com

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 COVID-19.

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 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.