ExpreS2ion announces financial results for the fourth quarter and full-year 2022

Hørsholm, Denmark, February 9, 2023– ExpreS2ion Biotech Holding AB (“ExpreS2ion”) today announces its fourth quarter and full-year financial results for 2022. The report is available as an attachment and on ExpreS2ion's website (www.expres2ionbio.com). Below is a summary of the report.

CEO Bent U. Frandsen comments

“In 2022, ExpreS²ion continued its journey towards becoming a stronger and more pipeline-driven biotechnology company with several high-value assets. Excellent progress was achieved in our leading development projects for COVID-19 and breast cancer, and our ExpreS2™ platform for the development and production of protein-based vaccines was included in its first Phase III evaluation.

Looking ahead, we are aiming to achieve several exciting milestones in 2023, including the Phase III study results for the ABNCoV2 COVID-19 vaccine and the completion of the preclinical program for our ES2B-C001 breast cancer vaccine and related clinical trial application submission.”

Fourth quarter (October – December 2022)

• Operating income amounted to 1,583 (4,430) KSEK.
• Profit/loss after financial items amounted to -53,287 (-14,944) KSEK.
• Profit/loss for the period amounted to -48,533 (-14,320) KSEK.
• Net income per share* amounted to -1.29 (-0.46) SEK.

Year-to-date (January – December 2022)

• Operating income amounted to 6,150 (13,730) KSEK.
• Profit/loss after financial items amounted to -126,581 (-47,516) KSEK.
• Profit/loss for the period amounted to -118,605 (43,925) KSEK.
• Net income per share* amounted to -3.38 (-1.50) SEK.
• End of period cash balance amounted to 110,974 (37,111) KSEK.
• End of period total assets amounted to 137,363 (151,956) KSEK
• End of period equity / asset ratio amounted to 75% (92%)**

Figures in parenthesis are the numbers from the same period in 2021.

*The Group’s net income per share: The net income for the period divided with the average number of shares for the period. For the period January to December 2022, the average number of shares amounted to 35,096,168. As of 31/12/2022, the total number of shares in ExpreS²ion Biotech Holding AB was 37,606,796.

**In Q4 2021 the Company decided to store cash in its account with the Danish tax authority (SKAT), where no interest is charged. See callout on balance sheet page.

***Equity ratio: Shareholder’s equity divided by total capital.

Significant events during the third quarter

• On October 6, ExpreS²ion Biotech Holding AB announced that Allan Rosetzsky, with immediate effect, had decided to resign from ExpreS2ion’s board of directors. Hereafter the board of directors will consist of Martin Roland Jensen (Chair), Jakob Knudsen, Karin Garre, and Sara Sande.

• On October 17, ExpreS²ion announced that follow-up results from Bavarian Nordic’s Phase II clinical trial for the ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 booster vaccine show that antibody titers remained high at levels associated with greater than 90% efficacy six months after vaccination for both the Wuhan and the Omicron variant.

• On October 24, ExpreS2ion announced that the journal Biomedicines published an article about the breast cancer vaccine candidate ES2B-C001 titled “Prevention and therapy of metastatic HER-2+ mammary carcinoma with a human candidate HER-2 virus-like particle vaccine”.

• On November 3, ExpreS2ion announced the establishment of an Oncology Scientific Advisory Board (OSAB). The six initial members of the ExpreS2ion OSAB bring a depth of knowledge in oncology, breast cancer, clinical trials and therapeutic HER2 vaccines, and will contribute to the development of ExpreS²ion’s proprietary HER2-cVLP breast cancer vaccine, ES2B-C001. The OSAB will serve as advisors, potential contributors to the planned clinical studies and participants in Key Opinion Leader events for the scientific community and investors.

• On December 6, ExpreS2ion announced that the company has signed a Vaccine Discovery Collaboration Agreement with Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”) for the joint development of a novel cytomegalovirus (CMV) vaccine candidate. The collaboration will combine ExpreS2ion’s ExpreS2 platform and resources for vaccine development and production with Evaxion’s RAVEN artificial intelligence (AI) platform for vaccine candidate discovery and state-of-the-art preclinical models. The aim of the collaboration is to, before the end of 2025, develop a novel CMV lead vaccine candidate, which ExpreS2ion has the exclusive right to license under a potential Development and Commercialization Agreement. The research costs and IP licensing for the collaboration project will be divided 50/50 between the parties until 2025, with all costs expected to be covered by each party’s existing budget.

Significant events after the end of the period

• On January 3, ExpreS2ion announced the appointment of Dr. Farshad Guirakhoo as the Company’s new Chief Scientific Officer (CSO). Dr. Guirakhoo has more than 30 years of broad translational research experience in the vaccine development field and will be responsible for directing the development of the discovery and preclinical strategies and plans that support ExpreS2ion’s development pipeline of unique vaccine assets, including managing the progression of ExpreS2ion’s vaccine technology platform. Dr. Guirakhoo starts his employment on January 16, 2023 at ExpreS2ion’s headquarters in Hørsholm, Denmark.

• On January 20, ExpreS2ion announced that that the journal The Lancet Microbe published an article about the COVID-19 vaccine candidate ABNCoV2 titled “First-in-human use of a modular capsid virus-like vaccine platform: an open-label, non-randomised, phase 1 clinical trial of the SARS-CoV-2 vaccine ABNCoV2” co-authored by ExpreS2ion scientists.

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This press release constitutes inside information that ExpreS2ion Biotech Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was sent for publication, through the agency of the contact persons set out below, at the time stated by the Company’s news distributor, Cision, at the publication of this press release.

For further information about ExpreS²ion Biotech Holding AB, please contact:
Bent U. Frandsen, CEO
Telephone: +45 4256 6869
E-mail: buf@expres2ionbio.com

Keith Alexander, CFO
Telephone: +45 5131 8147
E-mail: ka@expres2ionbio.com

About ExpreS2ion
ExpreS²ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS²ion Biotech Holding AB with company register number 559033-3729. ExpreS²ion has developed a unique technology platform, ExpreS², for fast and efficient non-clinical development and production of complex proteins for new vaccines and diagnostics. ExpreS² is regulatorily validated for clinical supply. The platform includes functionally modified glycosylation variants for enhanced immunogenicity and pharmacokinetics. Since 2010, the Company has produced more than 500 proteins and virus-like particles (VLPs) in collaboration with leading research institutions and companies. ExpreS²ion develops novel VLP based vaccines in association with AdaptVac ApS, of which ExpreS²ion owns 34%. For additional information, please visit www.expres2ionbio.com.