Analysis ExpreS2ion Biotech: Preparing for the final

Bavarian Nordic redesigning pivotal study
Bavarian Nordic still has a chance to kick off its pivotal phase 3 trial with ABNCoV2 in June, which is the timeline that has been communicated by the company. The study is being redesigned and will no longer be part of governmental booster programs but a separate randomized study on 4 000 patients in EU and US.

The primary endpoint will register the boost of neutralizing antibodies to the Wuhan strain of the COVID-19 virus two weeks after administration of the vaccine, either the ABNCoV2 or Pfizer’s Comirnaty. This design gives us good confidence, a 68 percent likelihood, that the candidate will be launched in late 2023.

Mounting competition in COVID-19 prevention
The planned phase 3 study will allow Bavarian Nordic to claim non-inferiority of ABNCoV2, a protein-based vaccine, to the market leader Comirnaty, a mRNA-based vaccine. This may prove to be a marketing challenge. However, the product will have the convenience of being stored in room temperature.

Furthermore, competitive pressure is building up with the approval in EU of Nuvaxovid, the first approved protein-based vaccine, and a few other vaccines down the line. And even more so, the likely approval of efficient Omicron-directed vaccines from Pfizer and Moderna should take the lead in a resurge of vaccinations expected to come in this fall.

Focus on proprietary breast cancer vaccine candidate
We are looking ahead with excitement to more data on the in-house development of ES2B-C001, ExpreS2ion’s proprietary therapeutic vaccine candidate for HER2+ metastatic breast cancer. The program has been delayed in preclinical development with about two years and the market is also seeing a lot of competition. Animal safety data in 2023 will be the next milestone and a phase 1 study may start in 2024.

Fair value lowered based on new challenges
ExpreS2ion Biotechnologies holds about a 1 percent stake in the future sales of ABNCoV2 and more importantly a 34 percent stake in AdaptVac, which holds a +10 percent stake in the program.

Mounting competition in the market leads us to lower the anticipated doses sold in 2023-27 to 225 million (260). Regulatory requirements on safety should not be neglected either, as can be seen in other development programs, such as Novavax’ and Valneva’s.

We are lowering the fair value of our base scenario for ExpreS2ion to SEK 30 (39), a consequence of both dilution and trimming of ABNCoV2 and ES2B-C001 valuation.