“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.

PDF