On May 8, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its results for the first quarter 2019 (Press release, BerGenBio, MAY 8, 2019, View Source [SID1234535900]).
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A presentation and live webcast by the Company’s management will take place today at 10.00 am CET in Oslo, please see below for details.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are pleased to see the positive strategic and clinical momentum generated in the last year continue into 2019. We have continued to see promising initial data emerging from the clinical development programme with bemcentinib, particularly in AML and NSCLC. We believe that this data provides us with sufficient evidence to begin the initiation of late stage clinical development in these indications during 2019. We are looking forward to providing an update on these data at the forthcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June."
Operational Highlights – First Quarter 2019
Lead candidate bemcentinib meets efficacy endpoint in combination with cytarabine in AML patients unfit for intensive therapy
Phase II trial evaluating bemcentinib in combination with low-intensity chemo-therapy in AML patients unfit for intensive therapy fully recruited
Bemcentinib in combination with Low-dose Cytarabine (LDAC) meets efficacy endpoint: Three out of 10 evaluable LDAC patients (30%) had CR/CRi
Combos warrant further expansion, meanwhile, company prepares for late stage bemcentinib monotherapy trial in later line elderly AML patients unfit for intensive chemotherapy
Phase II trial with bemcentinib and KEYTRUDA in NSCLC made important progress
Additional cohort (Cohort B) added under collaboration agreement with Merck & Co extending eligibility to patients who have disease progression on prior immune checkpoint inhibitors
Start of Phase II Investigator-Initiated Trial Evaluating Selective AXL Inhibitor bemcentinib in high-risk MDS
Up to 43 patients to be enrolled at leading MDS centres across Europe
Start of Phase I trial evaluating first-in-class anti-AXL antibody BGB149
BGB149, a wholly owned asset, is the first therapeutic anti-AXL monoclonal antibody to enter clinical development
Phase I study will investigate safety and pharmacokinetics in healthy volunteers
Start of phase I trial evaluating ADCT-601, a novel anti-AXL antibody drug conjugate (ADC), in patients with advanced solid tumours
ADCT-601 uses a proprietary AXL antibody developed by BerGenBio and licensed to ADC Therapeutics for ADC development
Phase I dose escalation and expansion trial will evaluate ADCT-601 in 75 cancer patients
Trial managed and sponsored by ADC Therapeutics
First clinical milestone met and milestone payment received
Preclinical data presented at AACR (Free AACR Whitepaper) reinforces bemcentinib’s potential to reverse tumour immunosuppression and therapy resistance
Extensive data in pre-clinical models of non-small cell lung cancer (NSCLC) and pancreatic cancer demonstrating AXL’s role in reversing tumour-mediated immunosuppression and therapy resistance presented at AACR (Free AACR Whitepaper)
bemcentinib shown to reverse AXL’s effects, thus acting synergistically with immune cells and anti-cancer therapies
Key appointments to executive team and Board to prepare organisation for next phase of development
Key appointments to executive team and Board to prepare organisation for next phase of development; Board of Directors strengthened. Grunde Eriksen, Debra Barker and Pamela Trail elected as new board members.
Dr Dominic Smethurst appointed as permanent Chief Medical Officer (CMO)
Favourable outcome of arbitration brought by BerGenBio against Rigel Pharmaceuticals clarifying the extent of Rigel’s entitlement to receive compensation in the event of a sale of BerGenBio, its assets, or a license to Bemcentinib
R&D grant of up to NOK 11 m awarded by Research Council of Norway
Financial highlights
Total operating expenses for the first quarter were NOK 54.5 million (Q1 2018 NOK 54.8 million)
Research and development expenses accounted for 70% of total operating expenses in Q1
Comprehensive loss for the first quarter amounted to NOK 44.3 million (Q1 2018 a loss of NOK 53.8 million)
Cash and cash equivalents amounted to NOK 306.7 million at the end of March 2019
Presentation and Webcast Details
A presentation by BerGenBio’s senior management team will take place today at 10:00 am CET at:
Felix Konferansesenter,
Bryggetorget 3,
0125 Oslo.
The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.
The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.