The anti-TNFR2 antibody is being tested in two arms in a phase I/IIa study. The first arm, with BI-1808 as a monotherapy, is now recruiting patients to the phase IIa part. The second arm, combining BI-1808 with pembrolizumab, is in phase I. The two phase IIa arms consist of different indication cohorts and will recruit around 180 patients, so this is a decent-sized study.

Data from the phase I part of the combination arm will be presented at ASCO from 31 May, while data from the single-agent phase II arm are expected by end-year 2024, which will be a significant catalyst.

BI-1910 is an antagonistic TNFR2 antibody. It is the youngest programme in the clinic, as the phase I part began in December 2023, so we will have to wait sometime to get data, with the first readout planned for the end of 2024.

BI-1206 is an anti-FcyRIIB antibody developed in lymphoma to prevent resistance to rituximab, the main lymphoma drug. In February, BioInvent announced a collaboration with AstraZeneca for a triplet study with their Calquence in lymphoma. The competitive situation for indolent non-Hodgin’s lymphoma, for which BI-1206 is being developed, will likely harden until 2030. Partly this is due to the introduction of efficacious CAR-T treatments (which, however, are tough treatments). But it is mainly because bispecifics, milder than CAR-Ts, are moving up the indication ladder, with approvals in the first line expected for Lunsumio, Epkinly, and odronextamab in 2029-2030. Lunsumio and odronextamab in combination with lenalidomide are competing with rituximab in the first while, while Epkinly is combined rituximab. This might lead to a reduction of the use of rituximab in the first- and second-line settings. We believe this has been part of the motivation for the triplet study of BI-1206 with AstraZeneca's Calquence, which could complement the positioning of BI-1206 as an add-on to rituximab monotherapy, while also providing grounds for a potential future deal. This being said, there will likely always be a place for rituximab due to its mild side-effect profile, especially in older patients, so the market for BI-1206 is unlikely to disappear.

The phase IIa intravenous part is still enrolling patients. In previous reports, the timeline communicated for a readout was the end of this year (2024), though no mention was made in this report. Bioinvent expects results from the phase I arm of the subcutaneous formulation before summer (H1). This is important because the IV version had infusion-related side effects, and minimising side effects is important to position the combination treatment as a mild alternative for older or more frail patients in later lines. The triple-combination with Calquence would likely be a frontline treatment for healthier patients who can handle side effects better, so the IV formulation is less of an issue there, though eventually the SC use would be used there as well. BioInvent expects a first readout from the triplet in Q4 2024.

In a phase II study of Calquence monotherapy in relapsed/refractory mantle cell lymphoma, where it is now approved, the ORR was 82% with a complete response rate of 48%. Although the cancer type is not identical to that of BI-1206’s study (mantle cell lymphoma is a subtype of indolent lymphoma), we believe this is a reasonable benchmark and that these rates would have to be surpassed by the triple combination.

The second study investigates how BI-1206 can counteract resistance to checkpoint inhibitors. Positive initial data has been reported from the phase I study and further data will be presented at ASCO from 31 May.

BI-1207 is the second anti-FcyRIIB antibody. The phase I study of BI-1607 in combination with trastuzumab was completed last year with positive results. A phase II study will start this year. The company is deliberating which combination regimen to choose before continuing.

BT-001 is an oncolytic virus that encodes a CTLA-4 antibody and is developed 50/50 with Transgene. Positive phase I monotherapy results were reported in 2023. However, it is generally assumed that oncolytic viruses will have to be combined with checkpoint inhibitors in metastatic disease. The results from the phase I study in combination with pembrolizumab are expected in H2 2024 and are essential for deciding whether to continue with the project.

The revenues of SEK6m were mainly related to production of antibodies and research services. Thanks to higher interest rates and the large cash position, net financial items amounted to SEK12m.

Costs were lower than the previous quarter at SEK-96m. Good cost controls combined with financial income and revenues result in a moderate quarterly loss of SEK-78m. We expect costs to increase as larger phase IIa studies are initiated in new programmes. The cash position decreased to 1.22bn (SEK1.28bn), which should last through Q1 2026.

Little has happened since our Q4 comments that affects our valuation assumptions. We have mainly made some changes to the cost forecasts based on Q1 costs coming in lower than we expected. We restate our base case of SEK83, with a bull case of SEK135 and a bear case of SEK33.

Our main valuation assumptions are listed in the table above. Other important assumptions about deals are: