BerGenBio

ASCO: more supportive data for bemcentinib

Update | 5 June 2019

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BerGenBio has presented further early Phase II proof-of-concept data at ASCO, which support bemcentinib’s potential in NSCLC and AML as a part of a combination regimen. Data in NSCLC shows that bemcentinib enhances pembrolizumab activity in patients with AXL-expressing tumours, particularly in PD-L1-negative tumours which do not normally respond to PD-1/PD-L1 monotherapy. In AML, combination with low dose chemotherapy in poor prognosis patients improves treatment outcomes. Safety data indicate that bemcentinib in combination is well-tolerated. Larger randomised Phase II studies are in planning; detail on these and additional clinical data is expected in H219. Ahead of this, we value BerGenBio at NOK3.14bn (NOK57.45/share).

Year-end: December 31201720182019E2020E
Sales (NOKm)0.02.3 0.00.0
Adj. PBT (NOKm)(182.2) (197.7) (240.2) (250.9)
Net Income (NOKm)(182.2) (197.7) (240.2) (250.9)
Adj. EPS (NOK)(4.0) (3.6) (4.4) (4.6)
Cash (NOKm)370.4 360.4 114.8 66.2*
EBITDA (NOKm)(183.5) (194.3) (239.3) (250.7)
Source: Trinity Delta; Note: *2020E cash includes a NOK200m capital raise. Adjusted numbers exclude exceptionals.
  • Continued durable response and survival data in NSCLC The Phase II bemcentinib + pembrolizumab NSCLC study (BGBC008) continues to show promise, especially in patients with AXL positive tumours (AXL+), including those with low or no PD-L1 expression. At data cut off, 35/46 pts were evaluable; 58% (19) were AXL+ and achieved an objective response rate of 40% irrespective of PD-L1 status, consistent with data from the first 10 pts (see February Outlook). 92% (32) patients had low or non-PD-L1 expressing tumours. ORR for all patients was 29%. Median overall survival of 12.2 months (for stage 1) compares favourably with 9.3 month mOS in 2L non-squamous NSCLC reported in KEYNOTE-001 Phase I pembro monotherapy.
  • Bemcentinib enhances chemo in poor prognosis AML BGBC003 data (low dose chemotherapy + bemcentinib) showed improved efficacy and survival duration in elderly AML patients ineligible for intensive chemotherapy. In the LDAC (low dose cytarabine) arm, ORR was 46% (6/13) – significantly higher than historic data for cytarabine monotherapy – with a 25% ORR (3/12) for the decitabine arm. Relapse free survival data is immature but reported as 6.2 and 5 months respectively.
  • Randomised Phase II trials in planning Detail on bemcentinib’s randomised Phase II programme is as yet undisclosed. We expect a focus on NSCLC and AML/MDS, given the promise shown to date, with trials designed to be potentially pivotal to support FDA/EMA filing and expedite the route to market. Confirmation of design of a PD-1/PD-L1 + bemcentinib NSCLC trial is pending H219 results from Cohort B (previously treated advanced NSCLC which has progressed on anti-PD(L)1 therapy).
  • NOK57.45/share (NOK3.14bn or $370m) valuation Our valuation suggests the potential of targeting AXL remains underappreciated, despite increasing recognition as an important oncology target. We believe that Phase II data from several trials of bemcentinib (the leading selective small molecule AXL inhibitor in development) over the coming year will further highlight its potential and catalyse the shares.

Update

5 June 2019

PriceNOK20.0
Market CapNOK1.099bn
Enterprise ValueNOK792m
Shares in issue54.9m
12-month rangeNOK17.44-45.50
Free float60.6%
Primary exchangeOslo
Other exchangesN/A
SectorHealthcare
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.

Analysts

Mick Cooper PhD
mcooper@trinitydelta.org
+44 (0) 20 3637 5042

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Exhibit 1: Summary of financials
Source: Company, Trinity Delta  Note: The short-term debt in FY20 is indicative of the company’s funding requirement

 

 

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