ExpreS2ion announces interim results for the first nine months of 2020

Hørsholm, Denmark, November 19, 2020 – ExpreS2ion Biotech Holding AB (“ExpreS2ion”) today announces its interim financial results for the first nine months of 2020 and the third quarter of 2020. The Interim Report (Q3) 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

“One reason – perhaps the main reason – I am so pleased with our recent capital raise is that we can now finally get to work on the HER2 VLP breast cancer vaccine AV001. There is a good chance that with the investments we make now, we will have a novel therapeutic vaccine that has shown solid immune responses in humans in a couple of years. And that is a very attractive position to be in.”

Third quarter (01/07/2020 to 30/09/2020)

• Net sales amounted to 3,141 (3,158) KSEK.
• Result after financial items amounted to -5,544 (-3,581) KSEK.
• Net income amounted to -4,887 (-2,944) KSEK.
• Net income per share* amounted to -0.30 (-0.22) SEK.

Nine months (01/01/2020 to 30/09/2020)

• Net sales amounted to 9,986 (10,218) KSEK.
• Result after financial items amounted to -16,432 (-12,139) KSEK.
• Net income amounted to -14,360 (-10,361) KSEK.
• Net income per share* amounted to -0.93 (-0.79) SEK.
• Cash flow from operating activities amounted to -8,501 (-10,878) KSEK
• Equity ratio** amounted to 1.8% (29.3%).
• Cash and cash equivalents amounted to 30,399 (2,628) KSEK.

Numbers in parenthesis are the numbers from the same period in 2019.

*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 July to September 2020, the average number of shares amounted to 16,283,367 and for the period January to September 2020, the average number of shares amounted to 15,363,612. As of 30/09/2020, the total number of shares in ExpreS²ion Biotech Holding AB was 16,365,891.

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

Significant events during the third quarter

• On July 8, ExpreS²ion announced that the cVLP COVID-19 vaccine license agreement negotiation between its joint venture AdaptVac and Bavarian Nordic is expected to continue beyond the previously announced two-month time frame. The timeline of the already fully funded Phase I/IIa trial is not affected. Process transfer to GMP manufacturing has been initiated, while Bavarian Nordic and AdaptVac continue to cooperate on vaccine scale-up and later phase clinical development activities.

• On July 14, ExpreS²ion announced that its ExpreS² platform will be used in the production of the novel Zika-HX vaccine candidate that is being developed by Excivion Ltd., a UK-based biotechnology company. The manufacturing of the Zika-HX vaccine will be conducted together with CPI, a British independent technology innovation centre and a founding member of the UK Government’s High Value Manufacturing Catapult.

• On July 17, ExpreS²ion announced that AdaptVac has announced publication of a paper in the journal Vaccines, where its broadly protective Flu cVLP vaccine induced a more potent, long-lasting immune response and was able to protect mice against both homologous and heterologous H1N1 influenza challenge, even after a single dose.

• On July 22, ExpreS²ion announced that its joint venture AdaptVac has entered into a final license agreement with Bavarian Nordic, to license the proprietary capsid virus like particle (cVLP) based SARS-CoV-2 subunit vaccine. Under the terms of the agreement, Bavarian Nordic will make an upfront payment of EUR 4 million to AdaptVac, in addition to potential future development as well as sales milestones and single to double-digit percentage-tiered royalties. The total deal value, excluding royalties is up to EUR 136 million, corresponding to SEK 1.4 billion. For application of its proprietary protein production system ExpreS², ExpreS²ion will retain up to EUR 2 million, corresponding to SEK 21 million, of the commercial milestone payments, which are estimated to be recognized as ExpreS²ion revenues during 2021 and 2022 in accordance with the current development plans, as well a double-digit percentage of AdaptVac’s royalty revenue stream.

• On August 3, ExpreS²ion announced that all warrants held by employees and Board members under the 2017 Warrant Program, established in April 2017, have been fully exercised. In total, 436,200 warrants were exercised, providing ExpreS²ion SEK 2,656,632. The exercise has increased the number of shares by 436,200, from 15,929,691 to 16,365,891.

• On August 18, ExpreS²ion announced that it wishes to exercise the option to inlicense AV001 before it expires on February 26, 2021. The exercise of the option is subject to the Company obtaining the necessary financing to fund the exercise of the option and the further preclinical development of AV001. If so, the Company expects to be able to submit an application to start clinical trials in the first half of 2022. The Company furthermore announced that it will transfer 16 percent of its joint venture ownership in AdaptVac to joint venture partner NextGen vaccines, following which ExpreS²ion will hold 34 percent and NextGen Vaccines 66 percent of AdaptVac when the option to in-license AV001 is exercised. The transfer of ownership provides AdaptVac with the autonomy needed as an independent commercial entity, further strengthen its ties to leading scientists at the University of Copenhagen and facilitates future capitalizations of AdaptVac independent of ExpreS²ion. These strategic measures will enable AdaptVac to continue developing valuable assets for our joint venture, without drawing on ExpreS²ion core resources.

• On August 18, ExpreS²ion announced that it has appointed Mr. Keith Alexander as new Chief Financial Officer (CFO). Mr. Alexander brings more than 20 years of corporate banking and strategy consulting experience and will initially be focused on strengthening the Company’s financial strategies and investor relations function. Mr. Alexander will begin his employment on October 1, 2020 and will be based out of ExpreS²ion’s headquarters in Hørsholm, Denmark.

• On August 19, ExpreS²ion provided a market update on its expectations to the development timelines of the COVID-19 vaccine prior to the release of the Company’s Q2 2020 report. The Company announced that it expects the phase III trials to commence as soon as the first half of 2021, with possible market launch before the end of 2021.

• On August 20, ExpreS²ion announced that the Company's half-year report for 2020 is published. The half-year report is available on ExpreS²ion's website (www.expres2ionbio.com).

• On August 25, ExpreS²ion announced that the Board of Directors of ExpreS²ion Biotech Holding AB has, subject to approval by the Extraordinary General Meeting to be held on September 23, 2020, resolved to carry out a share issue with preferential rights for the Company’s existing shareholders including warrants (the “Rights Issue” or the “Offering”). Upon full subscription of the Rights Issue, which is fully guaranteed, the Company will receive approx. SEK 131 million and upon full exercise of the warrants, the Company will receive up to an additional approx. SEK 85 million before deduction of costs related to the Offering. The proceeds allows the Company to continue its participation in the PREVENT-nCoV consortium to develop a novel COVID-19 vaccine, to exercise the option to in-license AV001, a promising therapeutic breast cancer vaccine and in general to effectuate the new strategy described in the Q1 2020 interim report on May 20, 2020 under which the Company combines its successful service business with the creation of an in-house pipeline of biopharmaceutical drug and vaccine candidates to maximize shareholder returns. 

• On September 10, ExpreS²ion announced that ExpreS²ion Biotech Holding AB’s affiliate ExpreS²ion Biotechnologies ApS would participate at several key events in September and October, including Aktiespararna’s Aktiedagen, September 15 in Lund, Sweden, the World Vaccine Congress Washington Virtual, September 28–October 1, and the World Vaccine Congress Europe Digital Event, October 19–21.

• On September 23, ExpreS²ion Biotech Holding held an extra general meeting. Resolutions that were passed are available in the press release that was published on September 23.

• On September 24, ExpreS²ion announced that its affiliate ExpreS²ion Biotechnologies ApS and the biotech tools company Attana AB have signed a heads of terms agreement regarding the development and supply of novel ExpreS²ion proteins to Attana. The first target protein will be the ExpreS²ion-produced SARS-CoV-2 spike and receptor-binding-domain (RBD) antigen used in ExpreS²ion’s COVID-19 vaccine program. Attana will now be able to offer customers utilising its AVA diagnostic platform this and other novel ExpreS²ion proteins. The parties are not disclosing the commercial terms of the agreement.

• On September 29, ExpreS²ion announced the launch of a significantly upgraded company website. The new website has a stronger focus on ExpreS²ion’s novel technology platforms and the Company’s pipeline project development. It also introduces a separate investor site for improved communication with shareholders, potential investors and other parties of interest.

• On September 29, ExpreS²ion published the prospectus in connection with capital raise of up to SEK 216 million. The prospectus had been approved by the Swedish Financial Supervisory Authority (Sw. Finansinspektionen).

Significant events after the end of the period

• On October 23, ExpreS²ion announced the completion of the rights issue of shares and warrants (“Units”) with last day for subscription on October 19, 2020 (the “Offering”). The Offering was subscribed to 142.2 percent. Through the Offering ExpreS²ion will receive proceeds amounting to approximately SEK 131 million before deduction of costs related to the Offering.

• On November 16, ExpreS²ion announced that the capsid virus like particle (cVLP) based COVID-19 vaccine, which is licensed to Bavarian Nordic, has been successfully manufactured with a full batch release to follow after final quality analysis. The project remains on track for presenting initial clinical Phase I/IIa results in Q1 2021, depending on the speed of the clinical trial application (CTA) approval procedure. Furthermore, the cVLP technology and manufacturing processes used are perfectly suited for rapidly manufacturing new vaccines in response to potential COVID-19 mutations.

Certified Adviser

Svensk Kapitalmarknadsgranskning AB

Telefon: +46 11 32 30 732

E-post: ca@skmg.se

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, please contact:

Bent U. Frandsen, CEO
Telephone: +45 4256 6869
E-mail: buf@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 300 proteins and 40 virus-like particles (VLPs) in collaboration with leading research institutions and companies. Since 2017, ExpreS²ion develops novel VLP based vaccines through its joint venture AdaptVac ApS. For additional information, please visit www.expres2ionbio.com and www.adaptvac.com.