“In short it has been a very exciting and successful year for ExpreS²ion, even though the COVID-19 pandemic took the company in an unexpected direction.

I would say that the first three months of 2020 became a defining period for the rest of the year. During this period, we started the PREVENT-nCoV consortium together with our joint venture company AdaptVac and other European entities, and the consortium subsequently received a 2.7 MEUR grant from EU’s Horizon 2020 program for the COVID-19 vaccine program (see our March 6, 2020 press release).

To put extreme amounts of effort into this project was a bit of a gamble, but I am confident that these were resources well spent, both for the company and as means to improve the global COVID-19 solution. As stated in our June 9, 2020 press release and later announcements, the ABNCoV2 COVID-19 vaccine is now on track to provide several key benefits if approved: excellent virus neutralization after just one dose, handling at ambient cooling temperatures and a vaccine structure well-suited for rapid modifications as new mutations of the virus become relevant.

While our development resources were primarily focused on rapidly advancing the ABNCoV2 COVID-19 vaccine towards the first clinical trial in 2021, we were able to report on progress in other areas as well during the year. The most important milestone reached was the acquirement of an option to in-license a unique HER2 breast cancer vaccine project from AdaptVac as stated in the February 26, 2020 press release, but we also saw progress in our influenza project as a member of the INDIGO consortium, with a 6.7 MSEK grant received from EU’s Horizon 2020 program as stated in our March 31, 2020 press release.

It is also important to highlight our successful financing efforts throughout the year. The main contributor of funds was the oversubscribed issue of units from which we received 131 MSEK in 2020 (see our October 23, 2020 press release), with outstanding warrants that could bring the total amount received up to a maximum of 216 MSEK. This capital provided us with the financial resources needed to push our inhouse-development efforts to a whole new level, with the in-licensing of the HER2 breast cancer project from AdaptVac after the end of the year (see our February 2, 2021 press release) really proving this point.”

Let us move on to your outlook for the rest of 2021 and thereafter. Can you start with summing up the status and outlook for the ABNCoV2 COVID-19 vaccine development program?
“Of course. We announced on January 8, 2021 that an application for a phase I/IIa clinical trial was submitted to the Central Committee on Research Involving Human Subjects (CCMO) in the Netherlands. The application is expected to be approved under a COVID-19 fast-track review procedure, which means that a decision will be made within 25 business days. Even with a few extra days added to this timeline for good measure during these pandemic times, a decision should be expected in the coming weeks, so these are exciting times for the program. Furthermore, the CTA submission is in line with the plans to present initial clinical Phase I/IIa results in Q1 2021. Importantly, the commercialization is led by the exclusive global licensee Bavarian Nordic, and we know they continuously seek alternative funding options for the later stage development, including governmental- and quasi-governmental funding, as well as other big pharma partners.”

I am sure that you also want to expand on the HER2 breast cancer development project that you recently in-licensed from AdaptVac. What are your plans for this project in coming years?
“As stated in a previous answer, we were able to reach the final agreement with AdaptVac just last week in the beginning of February 2021. This is truly exciting news for ExpreS²ion and something that I have personally been looking forward to ever since we acquired the option to in-license the project in Q1 2020. As the new project name ES2B-C001 suggests, we now have full control over the further development of this valuable asset, as well as an exclusive global license for its commercialization.

We are now continuing the pre-clinical activities in this project, with the aim to initiate the clinical program during the second half of 2022. This will start with GMP production of ES2B-C001 followed by the start of the first clinical study. Our goal is to start the clinical study in late 2022, but as stated in the February 2, 2021 press release, we may choose to start it in early 2023 if we need to allocate resources to facilitate the rapid clinical progress of the ABNCoV2 COVID-19 vaccine. Even though we are not running the COVID-19 clinical program, we are still following the global COVID-19 situation closely, including the recent rise of new mutations, and will be ready to provide our technology and know-how if the need should arise.”

How do you expect to advance your remaining inhouse development projects and partner development projects in 2021?
“Even though the ES2B-C001 HER2 breast cancer vaccine is our most advanced in-house pipeline project, we are also excited about our influenza vaccine project as a member of the EU Horizon 2020-funded INDIGO consortium. This project will continue to progress with further preclinical activities in 2021.

We are also expecting further progress in our partner malaria projects and will of course announce any significant news to the market when possible. So far, our academic partners at the University of Oxford (in charge of the clinical Phase II-stage blood-stage malaria vaccine) and University of Copenhagen (in charge of the clinical Phase I-stage pregnancy-associated malaria vaccine) have both experienced an effect on project progression due to the shift in focus to research within COVID-19, but they have each conveyed that a renewed focus on these projects will take place in 2021.

Finally, how are you planning to achieve these ambitious plans without being structurally bottlenecked?
“The recently announced efforts to strengthen our organization will surely support the further advancement of our pipeline projects. Additionally, we reduced our ownership in our joint venture AdaptVac in connection with the in-licensing of the HER2 breast cancer vaccine, which will increase ExpreS²ion’s  general focus on our own pipeline development while allowing for AdaptVac to thrive on its own terms so that our remaining holding has a good chance of rising in value. This is done while maintaining a close relationship as one of the largest shareholders in AdaptVac, as they might become a source of additional in-licensing opportunities for us in the future.

Ultimately, our management and Board is in total agreement on the fact that ExpreS²ion needs to constantly evolve as a company to meet the challenges ahead, combining a sound base strategy with being open to new opportunities such as the COVID-19 vaccine in 2021. This is how we will continue to build strong shareholder going forward, while addressing some of the most difficult medical challenges of our time.”