Focused on second-line NSCLC and AML

Update | 12 February 2020

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2019 marked another year of strong clinical progress with bemcentinib. BerGenBio is firmly focused on its development in non-small cell lung cancer (NSCLC) and acute myeloid leukaemia (AML) in the second-line (2L) settings, with promising clinical results so far. In 2L NSCLC, the mPFS of 8.4 months seen in AXL+ patients in Cohort A of the ongoing Phase II combination study with pembrolizumab is 4x more than would be expected with pembrolizumab monotherapy. In AML, the FDA has granted fast track status for bemcentinib in the treatment of elderly 2L AML patients; initial data from the current study with low dose cytarabine (LDAC) is promising with responses of >12 months. A recent private placement, raising NOK219.9m, enables BerGenBio to complete current clinical trials and the Phase Ib study with monoclonal antibody tilvestamab (BGB149). We value BerGenBio at NOK3.54bn (NOK48.31/share).

Year-end: December 31201820192020E2021E
Sales (NOKm)2.3 8.90.0 0.0
Adj. PBT (NOKm)(191.7) (199.3) (246.1) (286.9)
Net Income (NOKm)(191.7) (199.3) (246.1) (286.9)
Adj. EPS (NOK)(3.6) (3.4) (3.4) (3.9)
Cash (NOKm)360.4 253.6 227.5 51.5*
EBITDA (NOKm)(194.3) (203.6) (243.8) (286.2)
Source: Trinity Delta; Note: *2021E cash includes a NOK100m capital raise. Adjusted numbers exclude exceptionals.
  • Compelling data to date in NSCLC The latest reported mPFS for AXL+ patients (using a proprietary composite AXL tumour score) from Cohort A (immunotherapy [IO]-naïve) of the ongoing Phase II NSCLC trial with pembrolizumab is 8.4 months. This compares to 1.9 months in the AXL- patients, and an expected mPFS with pembrolizumab alone for this patient group (considering PD-L1 expression) of c 2 months. The efficacy endpoint for the first stage (n=13) of Cohort B (IO relapsed) has been met with ≥1 response, so 16 more patients are being recruited. Detailed data from Cohorts B and C (IO/chemo relapsed) are expected from mid-2020.
  • Waiting for more bemcentinib/LDAC data in AML Data with bemcentinib in AML to date, combined with the significant medical need for new 2L therapeutic options led to FDA grant of fast track designation. The ORR with bemcentinib monotherapy from the current Phase II AML study is 22%. Initial data in combination with LDAC is promising with an ORR of 36% in 1L/2L patients and duration of response of >1 year. Data from the expanded 2L arm is due in H220.
  • Deciding on the best routes to market BerGenBio has various registration strategies it could pursue in 2L settings in NSCLC and AML with bemcentinib. BerGenBio will decide on the best route forward by the end of the year and they will be based on market size considerations, scientific advice, and the data being generated in the ongoing trials.
  • Revised valuation of NOK48.31/share (NOK3.54bn or $416m)  We have updated our valuation to account for the NOK291.9m private placement (12.2m new shares at NOK18.00) and FY19 results. We now value BerGenBio at NOK 3.54bn or NOK48.31/share, compared to NOK3.31bn or NOK54.20/share previously.


12 February 2020

Market CapNOK1.29bn
Enterprise ValueNOK0.94bn
Shares in issue66.6m
12-month rangeNOK11.45-27.88
Free float64.3%
Primary exchangeOslo
Other exchangesN/A
Company CodeBGBIO
Corporate clientYes

Company description

BerGenBio is a clinical-stage, biopharmaceutical company based in Bergen, Norway and Oxford, UK. It is developing innovative therapies for aggressive cancers by way of inhibiting the Axl signalling pathway. The lead oncology compound, bemcentinib, is in multiple Phase II trials.


Lala Gregorek
+44 (0) 20 3637 5043

Mick Cooper
+44 (0) 20 3637 5042

Exhibit 1: Summary of financials
Source: Company, Trinity Delta Note: The short-term debt in FY21 is indicative of the company’s funding requirement.


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