BerGenBio

Earnings Release • Jun 22, 2023

BerGenBio Reports First Quarter 2023 Financial Results and Provides Business Update

BerGenBio Reports First Quarter 2023 Financial Results and Provides Business Update

Bergen, Norway, June 22, 2023 - 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 first

quarter ended March 31, 2023, and provided a business update.

"We recently reported the positive readout of several clinical trials that

strongly validate our strategy to concentrate our efforts on evaluating

bemcentinib to treat Non-Small Cell Lung Cancer patients harboring STK11

mutations," said Martin Olin, Chief Executive Officer of BerGenBio. "I would

like to thank our shareholders for their support of the recent Rights Issue,

providing gross proceeds of 250M NOK, allowing us to pursue the significant

opportunity in STK11m NSCLC. We look forward to sharing initial data from our

Phase 1a/2b trial in the second half of this year towards unlocking the value of

bemcentinib in NSCLC."

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 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)

The Company announced on March 9, 2023, that the first patient was enrolled in

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 STK11 mutations and no actionable mutations.

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. The Phase 2a expansion part 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 STK11 mutations.

A significant subgroup comprising approximately 20% (> 30,000 patients in US and

EU5) of non-squamous NSCLC patients harbor STK11 mutations, which are associated

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

Data suggests that STK11m NSCLC patients almost universally have AXL expression

and activation in tumors and/or on immune cells, resulting in the development of

drug resistance, immune evasion, and metastases.

The results of the BGBC008 (2L+ NSCLC, bemcentinib in combination with

pembrolizumab) and BGBIL005 (2L+ NSCLC, bemcentinib in combination with

docetaxel) trials 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 this provides strong

support for the ongoing BGBC016 1L NSCLC trial in patients harboring STK11

mutations.

2L+ NSCLC Trial (BGBC008)

InFebruary 2023the Company announced topline data from the Phase 2 BGBC008 2L+

NSCLCtrial and provided additional results from pre-planned analyses after

quarter end on May 15,2023. The trial enrolled 90 evaluable patients who

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

combination.

· A clinically meaningful survival benefit and evidence of disease control was

demonstratedwithbemcentinibin combination with pembrolizumab regardless of prior

therapy,providing a median overall survival (mOS) of 13.0 months (95% CI: 10.1,

16.7), medianprogression free survival (mPFS) of 6.2 months (95% CI: 4.6, 9.8),

disease control rate(DCR) of 51.1% (95% CI: 40.3, 61.8) and overall response

rate (ORR) of 11.1% (95% CI: 6.2,18.1).

· A significant (p-value < 0.05) and clinically meaningful improvement

inmOSbased on AXLIHC tumor scores was observed. Patients with AXL score > 5 (46%

of evaluable patients)achieved amOSof 14.8 months (95% CI: 12.4, 29.6) compared

to patients with AXL < 5,who achieved amOSof 9.9 months (95% CI: 6.7, 17.4). In

addition, patients with an AXL >5 had amPFSof 8.7 months (95% CI: 6.0, 14.8)

compared to 4.6 months (95% CI: 2.7, 8.1)for patients with AXL < 5. The ORR for

AXL > 5 was 21.9%.

· The observedmOSwas similar regardless of patient PD-L1 status.

· Treatment withbemcentinibin combination with pembrolizumab was well

-tolerated.

· Pre-planned biomarker analyses of patients in BGBC008 indicate that the

combination ofbemcentinib and pembrolizumab in patients with mutations

associated with pooroutcome with available standard of care therapies, including

STK11, KRAS, KEAP-1 andSMARCA4 mutations, may respond as if they have no

mutations in these genes.

At the 2023 AACR meeting, BerGenBio, its investigators and itscollaborator Merck

announcedfindings indicating benefit frombemcentinibin combination with

pembrolizumab treatment in2L NSCLC patients harboring KEAP1 mutations, which can

result in STK11 loss of function.Thesedata indicate that the relevant patient

populations who may benefit from the addition ofbemcentinibto standard of care

therapies may be broader than STK11m patients alone. Thiswill be further

assessed in the on-going BGBC016 study in 1L STK11m NSCLC patients.

2L+ NSCLC Trial (BGBIL005)

In Q4 2022, we announced that in addition to the encouraging ORR and DCR data

previouslypresented from the Investigator Led Study phase 1b/2a trial in

whichbemcentinibwascombined with docetaxel, the final mPFS of 3.1 months and mOS

of 12.3 months furthersupport the clinical benefit of combiningbemcentinibwith

chemotherapy.

Oncology: Relapsed/Refractory AML/MDS

Following the end of the quarter, the Company held a business update conference

call on May 15,2023, that included the topline results of the Phase 1b/2a

BGBC003 multicenter open-label studyofbemcentinibas a single agent and in

combination with low-dose cytarabine (LDAC) ordecitabine in patients with acute

myeloid leukemia or as a single agent in patients withmyelodysplastic syndrome.

· Two cohorts of patients in BGBC003 were treated withbemcentinibas a single

agent(monotherapy). In Cohort B1, in patients with Relapsed/Refractory (R/R)

AML, (n=11),bemcentinib provided an ORR of 18.2% and a mOS of 18 months. In

Cohort B4, in patientswith relapsed/high risk MDS, bemcentinib monotherapy

provided an ORR of 18.8% with a mOSof 9.2months. The Company believes the mOS

achieved is substantially longer than historicalcomparators in these same

patient populations, providing evidence of single-agent efficacy ofbemcentinib.

· Furthermore,bemcentinibin combination with LDAC appeared to provide

substantial mOSbenefit to patients with R/R AML (n=27) achieving an ORR of 18.5%

and a mOS of 8months.Although these findings are encouraging, the Company has

decided not to further pursueclinical trials in this indication given the change

in standard of care therapies in these patientpopulations.

Oncology: Mesothelioma

The topline results of the investigator led BGBIL011/MiST3 mesothelioma trial

were presentedpost-quarter on June 5, 2023, in an oral presentation at the 2023

American Society of ClinicalOncology (ASCO) meeting in an abstract

titled:Bemcentiniband pembrolizumab in patients withrelapsed mesothelioma:

MiST3, a phaseIIatrial with cellular and molecular correlates of efficacy.

MiST, the Mesothelioma Stratified Therapy umbrella trial, is a British Lung

Foundation fundedstudy dedicated to improving survival outcomes for patients

with mesothelioma.MiST3, the thirdarm of the trial, was designed to assess the

efficacy of AXL/PD-1 inhibition with the combinationofbemcentiniband

pembrolizumab.Key results include:

· 26 patients with relapsed mesothelioma were enrolled inMiST3and all received

at least onedose ofbemcentiniband pembrolizumab.

· The primary endpoint of disease control rate at 12 weeks (DCR12w) was met:

46.2% (90% CI:29.2, 63.4).

· Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of

38.5% (95% CI:20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95%

CI: 4.4, 34.9).

· The combination ofbemcentiniband pembrolizumab was generally safe and well

-tolerated.

Severe Respiratory Infections (SRIs)

The Company believes thatbemcentinibblocks viral entry and replication,

stimulates the innateimmune system, and promotes lung tissue repair positioning

it well for the treatment of severerespiratory infections.

BerGenBioannounced after the quarter on April 25, 2023, that after assessing the

significantdrop in hospitalizations attributed to COVID-19 during the 2022-23

winter season, the EU-SolidActTrial Steering Committee in accordance with the

Company decided to pause the Phase2b trial evaluatingbemcentinibin hospitalized

COVID-19 patients until a potential accelerationin hospitalizations warrant

further evaluation ofbemcentinibin this population. Previously theCompany has

completed two Phase 2 trials withbemcentinibin hospitalized COVID-19

patients,showing promising clinical activity.

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 will be dedicated to the conduct of

BGBC016 in 1L STK11mNSCLC patients, preclinical studies in severe respiratory

infections and forgeneral corporatepurposes.

Focused organizational structure aligned with strategy

Post quarter the Company has taken measures to further reduce its operational

costs includinga significant reduction in workforce and total compensation to

the executive management andthe board of directors. These prudent actions will

reduce total operating expenses by at least30% compared to historic operational

expenses when fully implemented.

Oncology Scientific Advisory Board

In February 2023,BerGenBioannounced the formation of a scientific advisory board

to enhancethe development ofbemcentinibfor the treatment of NSCLC patients with

STK11m, consistingof four world-renowned non-small cell lung cancer experts from

top oncology centers aroundthe globe: Enriqueta Felip, M.D., Ph.D., Head of the

Thoracic Cancer Unit at Valld'HebronUniversity Hospital, Spain; JohnHeymach,

M.D., Ph.D., Chair of Thoracic/Head and NeckMedical Oncology at the MD Anderson

Cancer Center, Texas; Tony Mok, M.D.,BMSc., Professorand Chairman of the

Department of Clinical Oncology at the Chinese University of Hong Kong;and

Solange Peters, M.D., Ph.D., Professor and Head of Medical Oncology and

ThoracicMalignancies at the Department of Oncology at Lausanne University,

Switzerland.

First Quarter 2023 Financial Highlights

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

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

-          Total operating expenses for the first quarter were NOK 72.4 million

(NOK 78.6 million)

-          The operating loss for the quarter came to NOK 72.4 million (NOK 78.6

million)

-          Cash and cash equivalents amounted to NOK 73.0 million at the end of

March 2023 (NOK 150.8 million by end of December 2022). In addition, post

quarter, the Company has secured NOK 250 million in gross proceeds from a rights

issue.

The Company provided a business update 15 May and a presentation hosted by

Arctic Securities and Carnegie 2 June 2023 in connection with the rights issue.

Presentations are available at the Company's

website. (https://www.bergenbio.com/investors/presentations) The company will

not host a webcast in connection with this quarterly update.

The Q1 2023 Financial Report is available at the Company's

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

-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

+47 90 55 16 98

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.