Trinity Delta Refining the route ahead

Refining the route ahead

Lighthouse | 20 August 2019

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BerGenBio continued to strengthen the data package for bemcentinib with the results presented at various conferences during Q219, including AACR and ASCO (see Update note). Importantly, the data continues to support the hypotheses that bemcentinib has promising activity MDS/AML and NSCLC, and can work synergistically with pembrolizumab (Keytruda) in NSCLC.
The data has also led to BerGenBio revising its clinical plans, and it is now going to expand the Phase II AML trial to include an arm with c 30 second-line, relapsed/refractory patients to receive bemcentinib in combination with LDAC (low-dose cytarabine), which will begin in Q319. There was an overall response rate (ORR) of 43% from all 14 evaluable patients (regardless of AXL expression) in the pilot study (vs historically c 18% with LDAC alone) with a heterogeneous patient populations and BerGenBio wants to evaluate the potential of this combination more thoroughly in a more homogeneous patient population before finalising the design of the pivotal study in AML.
The pivotal study with bemcentinib in AML is now due to start in H120, once it has analysed meaningful data from the expansion arm (open-label) and been able to finalise the clinical trial design. If results of the expansion arm are promising, the pivotal study will probably include patients being treated with bemcentinib monotherapy, bemcentinib with LDAC or standard-of-care.
Cohort B of the Phase II NSCLC trial has also being modified to include patients, who have progressed after receiving chemotherapy and PD‑1/PD‑L1 treatment and not just PD‑1/PD‑L1 (immuno-oncology, IO) relapsed patients. The amendment will better position bemcentinib for development in the second-line setting.
The pivotal study in NSCLC with bemcentinib in combination with a PD-1/PD-L1 inhibitor (probably pembrolizumab) is also expected to start in H120. The timing and final design of this trial depend on the results from Cohort B of the current Phase II NSCLC study.
The Phase I study with the AXL antibody BGB149 is nearing completion with no safety concerns identified to date and BerGenBio is now planning to initiate a Phase IIa trial in an undisclosed indication in H120, instead of a Phase Ib in Q419.
Further data is expected to be reported at conferences throughout H219. So far, BerGenBio expects to present more data from the NSCLC Phase II study with pembrolizumab at WCLC (7-10 September), ESMO (27 September-1 October and SITC (6-10 September); and more data from the Phase II trial AML with LDAC (low-dose cytarabine) reported at ASH (7-10 December)
The company finished Q219 with a cash position of NOK324m, after raising NOK73m (net) in a private placement in June.

Trinity Delta view: BerGenBio had another productive quarter in Q219. Notably, the initial Phase II data supports the further development of bemcentinib in MDS/AML in combination with LDAC, as well as monotherapy. Also, the second stage of the Phase II trial in NSCLC in combination with pembrolizumab is generating similar results to those seen in the first stage; while the total number of AXL-positive patients in this trial is still modest, the consistency of the results is encouraging.

The revisions to the clinical trial plan add a minor delay to the start of the pivotal programme, but provide very valuable information, which will help BerGenBio maximise the value of bemcentinib.

We value BerGenBio at NOK53.13/share (NOK3.21bn or $378m). We estimate that the company has sufficient capital to operate into H220, though this could be extended significantly through a licensing deal.

Lighthouse

20 August 2019


Price	NOK12.30
Market Cap	NOK745m
Primary exchange	Oslo
Sector	Healthcare
Company Code	BGBIO

Corporate client	Yes

Company description

BerGenBio is a clinical-stage, drug development company based in Bergen, Norway and Oxford, UK. It is developing innovative anti-cancer therapies that act on the promising Axl signalling pathway. The lead oncology compound, bemcentinib, is in a number of 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

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