ExpreS2ion Biotech : - Half-year report for 2020 published

Hørsholm, Denmark, August 20, 2020 - ExpreS2ion Biotech Holding AB ("ExpreS2ion") hereby announces that the company's half-year report for 2020 is published. The half-year 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

"Arguably, we just went through the most eventful quarter in our company's 10-year history. Most importantly, we announced a manufacturing agreement with AGC Biologics, a licensing deal between AdaptVac and Bavarian Nordic, and not least, very promising animal data from the COVID-19 vaccine."

Second quarter (01/04/2020 to 30/06/2020)

· Group turnover amounted to 4,016 (4,339) KSEK.
· Result after financial items amounted to -4,953 (-3,602) KSEK.
· Net income amounted to -4,239 (-3,076) KSEK.
· Net income per share* amounted to -0.27 (-0.23) SEK.

First half-year (01/01/2020 to 30/06/2020)

· Group turnover amounted to 6,845 (7,060) KSEK.
· Result after financial items amounted to -10,888 (-8,558) KSEK.
· Net income amounted to -9,473 (-7,417) KSEK.
· Net income per share* amounted to -0.64 (-0.58) SEK.
· Cash flow from operating activities amounted to -9,292 (-7,233) KSEK
· Equity ratio** amounted to 14.8 (39.2) %.
· Cash and cash equivalents amounted to 12,764 (5,013) 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 second quarter of 2020. For the period April to June 2020, the average number of shares amounted to 15,817,281. As of 30/06/2020, the total number of shares in ExpreS[2]ion Biotech Holding AB was 16,102,534.

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

Significant events during the second quarter

·
On April 21, ExpreS[2]ion announced that SEK 1.75 million (excluding accrued interest) of the loan provided by Modelio Equity AB will be converted into new shares at a price of SEK 6.4925 (corresponding to the last 15 trading days volume-weighted average share price).

·
On April 24, ExpreS[2]ion announced that its joint venture AdaptVac and AGC Biologics, a global Contract Development and Manufacturing Organization (CDMO) for Biopharmaceuticals, enters into a partnership for the scale-up and cGMP manufacture of the COVID-19 vaccine developed by the PREVENT-nCoV consortium. The partnership between AdaptVac and AGC Biologics has the potential to advance the initiation of the first clinical trial to the end of 2020.

·
On May 4, ExpreS[2]ion announced that SEK 1.75 million (excluding accrued interest) of the loan provided by Modelio Equity AB ("Modelio") will be converted into new shares at a price of approximately SEK 9.06 (corresponding to a 10 % discount off the last 15 trading days volume-weighted average share price). Following this conversion, there is no remaining outstanding SEK 5 million bridge loan to Modelio. In parallel, a new combination of a loan and a loan facility totaling up to SEK 6.5 million provides new working capital funding to the Company.

·
On May 6, ExpreS[2]ion announced that its joint venture AdaptVac has entered into an exclusive head of terms agreement with Bavarian Nordic, a global leader in the development, manufacture, and commercialisation of life-saving vaccines, to license the COVID-19 vaccine. The parties seek to enter into the final license agreement within the next two months. Upon execution of a final license agreement, Bavarian Nordic will pay AdaptVac an initial upfront payment in addition to future development and sales milestones and royalties. ExpreS[2]ion will retain a portion of the future milestone payments and royalties of AdaptVac's revenue stream.

·
On May 26, the Annual General Meeting (AGM) of ExpreS[2]ion Biotech Holding AB was held. A summary of the resolutions is available on the Company's website (www.expres2ionbio.com).

·
On June 9, ExpreS[2]ion announced that the capsid virus-like particle (cVLP) COVID-19 vaccine being developed by ExpreS[2]ion and its joint venture AdaptVac has demonstrated excellent COVID-19 immunisation with a very high level of SARS-CoV-2 virus neutralisation in animal proof-of-concept data, thus reaching an important pre-clinical milestone ahead of schedule.

Significant events after the end of the period

·
On July 8, ExpreS[2]ion 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 months' 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 22, ExpreS[2]ion announced that its joint venture AdaptVac has entered into a final license agreement with Bavarian Nordic A/S ("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 the application of its proprietary protein production system ExpreS[2], ExpreS[2]ion will retain up to EUR 2 million, corresponding to SEK 21 million, of the commercial milestone payments, which are estimated to be recognised as ExpreS[2]ion 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 18, ExpreS[2]ion announced that ExpreS[2]ion wishes to exercise the option to in-license 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 ExpreS[2]ion 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 capitalisations of AdaptVac independent of ExpreS[2]ion. These strategic measures will enable AdaptVac to continue developing valuable assets for our joint venture, without drawing on ExpreS[2]ion core resources.

·
On August 18, ExpreS[2]ion 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 ExpreS[2]ion's headquarters in Hørsholm, Denmark.

·
On August 19, ExpreS[2]ion 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 now expects the phase III trials to commence as soon as the first half of 2021, with possible market launch before the end of 2021.

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Svensk Kapitalmarknadsgranskning AB

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For further information about ExpreS[2]ion, please contact:

Bent U. Frandsen, CEO
Telephone: [phone]
E-mail: [e-mail]
 

This press release constitutes inside information that ExpreS[2]ion 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 above, at the time stated by the Company's news distributor, Cision, at the publication of this press release.

About ExpreS[2]ion

ExpreS[2]ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS[2]ion Biotech Holding AB with company register number 559033-3729. ExpreS[2]ion has developed a unique technology platform, ExpreS[2], for fast and efficient non-clinical development and production of complex proteins for new vaccines and diagnostics. ExpreS[2] 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, ExpreS[2]ion develops novel VLP based vaccines through its joint venture AdaptVac ApS. For additional information, please visit www.expres2ionbio.com and www.adaptvac.com.

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