BerGenBio

Earnings Release • Nov 14, 2023

BerGenBio Reports Third Quarter 2023 Financial Results

BerGenBio Reports Third Quarter 2023 Financial Results

BERGEN, Norway, November 14, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

bio-pharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, today announced financial results for the quarter

ended September 30, 2023, and provided a business update.

"We are pleased to report continued advancement of our focused strategy to study

our lead compound bemcentinib, a highly selective AXL inhibitor, in first line

(1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring mutations in the

STK11 gene (STK11m). The increasing recognition of STK11m as a poor prognostic

factor for 1L NSCLC patients, as evidenced by real-world data presented at

prestigious medical conferences, continues to substantiate high unmet medical

needs and our clinical data continues to validate the potential role of

bemcentinib in combination with standard of care therapies to improve the

outcome for these patients. During the quarter, we activated additional clinical

trial sites in the US and prepared for the addition of sites in Europe in

anticipation of the expected initiation of the Ph2a portion of our study in 1L

NSCLC STK11m patients in the first half of 2024. Our operating expenses in the

quarter amounted to NOK 28.1 million compared to NOK 62.4 million in Q3 2022

reflecting the effects of our focused strategy and cost containment implemented

in connection with the Rights Issue. At 30th September 2023 our cash position

stood at NOK 169.3 million. We believe that our singular focus on advancing

bemcentinib in 1L NSCLC STK11m combined with the potential funding from the

exercise of outstanding warrants issued in the Rights Issue enable us to

generate data that can position the significant potential of bemcentinib in

NSCLC," said Martin Olin, Chief Executive Officer of BerGenBio.

Clinical Development

Bemcentinib

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

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

expressed and activated in response to oxidative stress, inflammation, hypoxia

and drug treatment, resulting in several deleterious effects in cancer and

severe respiratory infections. Bemcentinib selectively inhibits AXL activation

to prevent the progression of serious diseases through the modulation of

resistance mechanisms and the adaptive immune system.

Bemcentinib is currently being developed in 1L STK11 mutated NSCLC and severe

respiratory infections. Its novel mechanisms of action and primary accumulation

in the lungs uniquely position it to address these severe lung diseases.

Oncology: NSCLC

1L STK11m NSCLC (BGBC016)

We continue to advance our focused strategy through the conduct of BGBC016, a

global, open-label Phase 1b/2a trial designed to determine the safety,

tolerability and efficacy of bemcentinib in combination with standard of care

treatments in untreated advanced/metastatic non-squamous NSCLC patients with

STK11m and no actionable mutations.  Sites in the US have been activated and

enrollment is ongoing while expansion into European sites is well underway, with

regulatory approval to proceed received from regulatory authorities in the US

and several European countries.

The Phase 1b portion of the study is evaluating the safety and feasibility of

three different doses of bemcentinib in combination with pembrolizumab and

doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients,

regardless of STK11 status. To date, no significant safety concerns have arisen

in the Phase 1b study.  The Phase 2a expansion will assess the safety and

efficacy of up to two doses of bemcentinib in the same treatment combination in

1L advanced/metastatic non-squamous NSCLC patients with STK11m.

A significant subgroup comprising of up to 20 % (> 30,000 patients in US and

EU5) of 1L non-squamous NSCLC patients harbor STK11m, which are associated with

immunosuppression and poor prognosis with standard 1L NSCLC treatment. Data

suggests that STK11m NSCLC patients almost universally express AXL in tumors

and/or on immune cells, resulting in the development of drug resistance, immune

evasion, and metastases.

Post-quarter, the Company announced that the final data from the BGBC008 study

(2L+ NSCLC, bemcentinib in combination with pembrolizumab) presented on October

23rd at the European Society for Medical Oncology (ESMO) 2023 Annual Meeting

held in Madrid.  The Company believes that these data along with study BGBIL005

(2L+ NSCLC, bemcentinib in combination with docetaxel) provide clinical evidence

of the anti-tumor effects of bemcentinib and its ability to modulate the tumor

microenvironment to enhance the effects of immunotherapy and chemotherapy. We

believe that the reversal of the effects of AXL with bemcentinib holds the

promise of providing substantial survival benefits to NSCLC patients and

specifically in patients harboring STK11m and potentially other hard-to treat

mutations such as KRAS and KEAP1.  We expect to report additional clinical data

at upcoming major medical meetings during the remainder of 2023, including the

Society for Immunotherapy of Cancer (SITC) Annual Meeting and the American

Society of Hematology (ASH) Annual Meeting.

Description of the 2L+ NSCLC Trial (BGBC008)

The Ph2 BGBC008 trial enrolled 90 evaluable 2L+ NSCLC patients who had received

at least one prior line of therapy:chemotherapy, immunotherapy or the

combination.

· An analysis of AXL biomarker status indicates that the presence of AXL

expression on either tumor cells and/or immune cells is predictive of improved

survival in patients treated with bemcentinib + pembrolizumab. The vast majority

(88%) of patients met the criteria for AXL presence (AXL positive patients) and

obtained clinically meaningful benefits:

· Median overall survival was highly statistically significant at p=0.001 in

AXL positive vs. AXL negative patients (14.1 mos. vs 6.5 mos).

· Median progression free survival was 6.0 mos. in AXL positive patients vs.

5.8 AXL negative patients.

· Analysis of available data for patients treated in subsequent therapies

(3L+) following treatment with bemcentinib + pembrolizumab identified a higher

than expected response rate, potentially pointing to long-lasting immune

response benefits.

· Data from the BGBC008 study also indicate that patients with PD-L1 negative

(TPS score <1%) benefit from the combination treatment of bemcentinib and

pembrolizumab.  Currently PD-L1 negative patients respond less well to immune

checkpoint inhibition, potentially providing an opportunity to expand the

patient population eligible for treatment with bemcentinib.

· The combination ofbemcentinib and pembrolizumab appeared to benefit patients

with mutations associated with pooroutcome with available therapies, including

STK11, KRAS, KEAP-1 andSMARCA4 mutations. These mutational patient populations

may represent an incremental opportunity for bemcentinib and will be further

assessed in our on-going BGBC016 study in 1L NSCLC patients.

Severe Respiratory Infections (SRIs)

The Company believes thatbemcentinibblocks viral entry and replication,

stimulates the innateimmune system, and promotes lung tissue repair positioning

it for the treatment of severerespiratory infections.

On April 25, 2023, the Company decided to pause the bemcentinib arm of the

Phase2b EUSolidAct trial evaluatingbemcentinibin hospitalized COVID-19 patients

due to the limited number of hospitalizations observed across all European

countries.  The Company and the EU-SolidAct have agreed to maintain this study

on pause until and unless such time both parties agree to resume the trial arm

due to increased COVID hospitalizations or should a new pandemic arise.

Bemcentinibis currently being evaluated in preclinical studies for SRIs causing

Acute RespiratoryDistress Syndrome (ARDS) and initial results are expected

during 2023.

Corporate Activities

Rights Offering

On June 13, 2023, the Company completed a rights issue raising gross proceeds

ofNOK 250m.The proceeds from this offering including any additional proceeds

from the exercise of warrants will be dedicated to the conduct of BGBC016 in 1L

STK11mNSCLC patients, preclinical studies in severe respiratory infections and

forgeneral corporatepurposes.

Warrants

The outstanding warrants issued in the Rights Issue can be exercised in two

defined windows; from 15 November 2023 09:00 am CET to 28 November 2023 4:30 pm

CET, or 1 April 2024 to 14 April 2024 at an exercise price of the volume

-weighted average price (VWAP) of the Company's shares on the Oslo Stock

Exchange over the three last trading days prior to the exercise period less 30%,

but in any event not less than NOK 0.10 and not higher than NOK 0.13. Additional

information and instructions for exercise of warrants can be found on the

Company's website (https://www.bergenbio.com/investors/investor

-relations/warrants).

Our Chief Operating Officer James Barnes, decided to pursue new opportunities

and will leave the company during December 2023. In connection with the

implementation of the focused strategy, the role of Chief Operating Officer will

not be replaced.

Third Quarter 2023 Financial Highlights

(Figures in brackets = same period 2022 unless otherwise stated)

-          Revenue was NOK 0 million (NOK 0 million) for the third quarter.

-          Total operating expenses for the third quarter were NOK 28.1 million

(NOK 62.4 million)

-          The operating loss for the quarter came to NOK 28.1 million (NOK 62.4

million)

-          Cash and cash equivalents amounted to NOK 169.3 million by the end of

September 2023 (NOK 226.0 million by end of June 2023).

Presentation and Webcast Details

The Q3 2023 presentation and Financial Report are available at the Company's

website (https://www.bergenbio.com/investors/financial-reports).

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/20231114_1/ (https://eur03.

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

ngpage%2Fhegnarmedia%2F20231114_1%2F&data=05%7C01%7Crune.skeie%40bergenbio.com%7C

1fd0ccaebb9f4d3fb3b808dbce1d0f3b%7C2b50b422ca6d42af9fc0741b248bb071%7C0%7C0%7C638

330396444059263%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBT

iI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=YjunypihEEXae6fFWZiIFPkoFSz0mFwmy

vfTMnxhS0A%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.

-End-

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 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

About Bemcentinib

Bemcentinib is a potentially first-in-class, potent and highly selective

inhibitor of the tyrosine kinase AXL.  Extensive studies confirm the ability to

combine bemcentinib with immune checkpoint inhibitors, chemotherapies and

targeted therapies with the goal of improving a patient's immune response and

delaying the development of chemoresistance.  Bemcentinib is currently being

investigated in combination with immune checkpoint inhibition and chemotherapy

in first line NSCLC patients harboring mutations in the STK11 gene, a known

prognostic factor of poor response to existing therapies.

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.