BERGEN, Norway, Feb. 11, 2020 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, announces its results for the fourth quarter and full year 2019.

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: "I am pleased to report on another eventful quarter for BerGenBio. During the period bemcentinib was approved for Fast Track Designation by the USA FDA for AML, and we continued to see encouraging data emerge from our ongoing phase II clinical trials with bemcentinib. The primary endpoint was met in our lung cancer trail in combination with Merck's checkpoint inhibitor Keytruda®. We were particularly pleased to see responses among patients for whom checkpoint inhibitors would not usually be expected to be effective. In January we reported achieving a similar endpoint in NSCLC patients who had previously relapsed on checkpoint inhibitors. Looking forward, we anticipate reporting clinical and translational data updates at medical conferences, later in the year. In January we closed a PIPE funding providing an additional NOK 220m, subject to EGM approval, such that the Company is well-financed well beyond current milestones."

Operational Highlights - fourth quarter and full year 2019

• Bemcentinib met primary endpoint in first cohort of Phase II NSCLC study in combination with KEYTRUDA®
• Primary endpoint, Overall Response Rate, was been met in predominantly PD-L1 negative/low patients
• Secondary endpoint, median Progression Free Survival, exceeds expectations in AXL positive patients
• Data was presented at Society for Immunotherapy of Cancer 34th Annual Meeting on 8 November 2019
• Preliminary clinical data from Phase II combination trial of bemcentinib and LDAC in elderly AML patients at ASH 2019
• Phase II trial data showed bemcentinib in combination with low-dose cytarabine (LDAC) in elderly AML patients unfit for intensive therapy is well tolerated and shows promising efficacy
• Long duration of response (>9.9 mo., still maturing) with 50% complete response (CR/Cri) in 6 evaluable newly diagnosed patients receiving the bemcentinib-LDAC combination 
• Clinical benefit demonstrated in >2L relapsed and refractory AML patients with 1 CR/CRi and 3 SD out of 6 evaluable patients 
• Data presented in a poster presentation at the 61st Annual American Society of Hematology (ASH) Meeting, on 7-10 December in Orlando, Florida.
• U.S. Food and Drug Administration (FDA) approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed.

With this Fast Track designation, BGB is eligible for:

• More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
• Eligibility for Accelerated Approval and Priority Review
• Clinical trial updates were presented at several major cancer scientific congresses and consistently confirm that NSCLC and AML are the optimal target indications
• Phase II development programme read-outs according to plan
• AML bemcentinib + LDAC: readouts at American Society of Clinical Oncology (ASCO) and European Haematology Association (EHA)
• NSCLC bemcentinib + KEYTRUDA: readouts at ASCO, World Conference on Lung Cancer (WCLC), European Society of Medical Oncology (ESMO), The Society for Immunotherapy of Cancer (SITC)
• Proprietary composite AXL tumour-immune (cAXL) score developed to identify & diagnose patients that show durable benefit
• Completed Phase Ia trial with tilvestamab (BGB149) in healthy volunteers
• Continued to build out the organisation with strategic medical, clinical, operational and regulatory hires
• Private placement completed in June, raising NOK 74.2 million

Q4 2019 / FY 2019 Financial Highlights

(Figures in brackets = same period 2018 unless otherwise stated)

• Revenue amounted to NOK 0.2 million (NOK 2.3 million) for the fourth quarter and NOK 8.9 million (NOK 2.3 million) for the full year 2019
• Total operating expenses for the fourth quarter were NOK 59.3 million (NOK 53.2 million) and total operating expenses for the full year 2019 amounted to 213.3 million (NOK 196.9 million)
• Research and development expenses accounted for 77% (74%) of total operating expenses in the full year 2019
• The operating loss for the quarter came to NOK 59.1 million (NOK 50.9 million) and NOK 204.4 million (NOK 194.5 million) for the full year 2019, reflecting the level of activity related to the clinical trials BerGenBio is conducting
• Cash and cash equivalents amounted to NOK 253.6 million at the end of December 2019 (NOK 360.4 million)

Post-period events

Private placement of NOK 219.9 million successful placed through new share allocation

• Net proceeds to be used to advance bemcentinib trial programs in AML and NSCLC, manufacturing scale-up of bemcentinib, biomarker and companion diagnostic development, and phase 1b development of tilvestamab.

Presentation and Webcast Details

A presentation by BerGenBio's senior management team will take place today at 10:00 am CEST at:

Hotel Continental
Stortingsgata 24/26, Oslo

The presentation will be 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.

About BerGenBio

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers. The company's proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad Phase II oncology clinical development programme focused on combination and single agent therapy in lung cancer and leukaemia. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is undergoing Phase I clinical testing. In parallel, BerGenBio is developing companion diagnostic tests to identify those patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting a precision medicine-based commercialisation strategy. 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, visit www.bergenbio.com 

Contacts:

Richard Godfrey CEO, BerGenBio ASA
+47-917-86-304

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47-917-86-513

International Media Relations

Mary-Jane Elliot, Chris Welsh, Lucy Featherstone, Carina Jurs
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44-20-3709-5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47-995-13-891

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.

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SOURCE BerGenBio ASA